InVivo Therapeutics Announces Exchange of Certain Warrants for Common Stock

Posted On August 11, 2017 By OrthoSpineNews In Financial /

August 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today announced that it had exchanged certain outstanding warrants that were issued as part of a financing in 2014 (the “2014 Warrants”) for shares of the company’s common stock.

The 2014 Warrants have anti-dilution features such that the exercise price of the warrants decreases if the company sells shares of its common stock for consideration below the exercise price of the 2014 Warrants, and upon certain other events. In addition, the number of warrants increases inversely to the exercise price decrease. These features can lead to extreme levels of dilution to existing shareholders and can be a significant barrier for potential new investors.

The company negotiated individual exchange agreements with certain of the holders of the 2014 warrants, whereby warrants representing the vast majority of the existing 2014 Warrants were exchanged for 2,021,419 new shares of common stock. As a result of the issuance of the shares of common stock, the exercise price and number of shares subject to the remaining 2014 Warrants were adjusted.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “We believe that these exchange agreements benefit our shareholders and the company by creating a substantially cleaner balance sheet for the company and removing a significant financial overhang. This puts us in a much stronger financial position as we work toward reopening enrollment in The INSPIRE Study and delivering on our mission for spinal cord injury patients.”

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the impact of the exchange agreements on the Company’s balance sheet and financial position. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended June 30, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.com

Vericel Reports Second-Quarter 2017 Financial Results

Posted On August 11, 2017 By OrthoSpineNews In Financial /

CAMBRIDGE, Mass., Aug. 09, 2017 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leading developer of expanded autologous cell therapies for the treatment of patients with serious diseases and conditions, today reported financial results for the second quarter ended June 30, 2017.

Total GAAP net revenues for the quarter ended June 30, 2017 were approximately $17.0 million and included approximately $12.9 million of MACI^® (autologous cultured chondrocytes on porcine collage membrane) and Carticel^® (autologous cultured chondrocytes) net revenues and approximately $4.1 million of Epicel^® (cultured epidermal autografts) net revenues, compared to $8.9 million of Carticel revenues and $3.8 million of Epicel revenues, respectively, in the second quarter of 2016. Total GAAP net revenues increased 32% compared to the second quarter of 2016, with MACI and Carticel revenues increasing 44% and Epicel revenues increasing 6%, respectively, compared to the same period in 2016.

MACI and Carticel GAAP net revenues include a partial reversal of a revenue reserve established in the first quarter of 2017. In April 2017, the company received notification of a contractual dispute between a contracted service provider and a third-party payer related to certain insurance reimbursement claims associated with Carticel and MACI surgeries performed in 2016 and 2017. This dispute was subsequently resolved and the negotiated reimbursement resulted in the company’s ability to recognize $1.4 million in additional MACI and Carticel revenue in the second quarter. Excluding the $1.4 million partial reversal of the revenue reserve, total revenues increased 21% and MACI and Carticel net revenues increased 28%, respectively, compared to the second quarter of 2016.

Gross profit for the quarter ended June 30, 2017 was $9.3 million, or 55% of net revenues, compared to $5.5 million, or 43% of net product revenues, for the second quarter of 2016.

Research and development expenses for the quarter ended June 30, 2017 were $3.0 million compared to $4.1 million in the second quarter of 2016. The reduction in second-quarter research and development expenses is primarily due to a reduction in ixCELL-DCM clinical trial expenses.

Selling, general and administrative expenses for the quarter ended June 30, 2017 were $8.8 million compared to $6.4 million for the same period a year ago. The increase in selling, general and administrative expenses is primarily due to an increase in expenses for marketing initiatives related to the launch of MACI and an increase in personnel costs primarily related to an increase in the MACI sales force.

Loss from operations for the quarter ended June 30, 2017 was $2.5 million, compared to $5.0 million for the second quarter of 2016. Material non-cash items impacting the operating loss for the quarter included $1.3 million of stock-based compensation expense and $0.8 million in depreciation expense.

Other income for the quarter ended June 30, 2017 was $0.1 million compared to $1.9 million for the same period in 2016. The change in other income for the quarter is primarily due to interest expense on the outstanding revolving credit agreement and term loans and the change in the fair value of warrants in the second quarter of 2017 compared to the same period in 2016.

Vericel’s net loss for the quarter ended June 30, 2017 was $2.4 million, or $0.07 per share, compared to a net loss of $3.0 million, or $0.22 per share, for the same period in 2016.

As of June 30, 2017, the company had $14.0 million in cash compared to $23.0 million in cash at December 31, 2016.

“We had a very strong second quarter driven by the accelerating uptake of MACI,” said Nick Colangelo, president and CEO of Vericel. “Our robust revenue growth and margin expansion reflect the success of our commercial team’s sales and marketing initiatives coupled with strong physician enthusiasm for MACI.”

Recent Business Highlights
During and since the second quarter of 2017, the company:

Achieved 28% growth in total MACI and Carticel net product revenues for the second quarter of 2017 compared to the same period in 2016, excluding the impact of a $1.4 million partial reversal of a revenue reserve;
Achieved gross margins of 51% of total net revenues in the second quarter of 2017 versus 43% in the same period in 2016, excluding the impact of a $1.4 million partial reversal of a revenue reserve;
Trained more than 350 surgeons on the MACI surgical procedures to date, with approximately 50% of trained surgeons coming from former Carticel user and non-Carticel user segments;
Increased biopsies 23% in the second quarter and 20% for the first half of 2017, respectively, compared to the same periods in 2016;
Medical benefit policies updated to include MACI at multiple commercial plans, including 18 of the top 28 commercial plans, which we believe represent approximately half of covered lives;
Executed a distribution agreement with Orsini Healthcare Services for MACI to ensure consistent and broad patient access and launched a standalone patient case management service for patient support services for MACI;
Announced the presentation of outcomes data from over 950 severe burn patients treated with Epicel demonstrating a probable survival benefit at the 49th annual meeting of the American Burn Association;
Received the FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ixmyelocel-T for the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy; and
Licensed the company’s product portfolio to Innovative Cellular Therapeutics for distribution in China, South Korea, and other countries in Southeast Asia.

“While our focus remains on our commercial portfolio, the RMAT designation for ixmyelocel-T opens up a number of exciting possibilities for the future of the program,” added Mr. Colangelo. “Likewise, the license of our product portfolio to ICT provides an opportunity to develop a global footprint for our product portfolio and to create another potential revenue stream for the company. We believe that these results position the company for strong growth in both the short and long term.”

Conference Call Information
Today’s conference call will be available live at 8:00am Eastern time in the Investors section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s second-quarter 2017 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at http://investors.vcel.com/events.cfm until August 9, 2018. A replay of the call will also be available until 11:00am (EDT) on August 13, 2017 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 54878623.

About Vericel Corporation
Vericel develops, manufactures, and markets expanded autologous cell therapies for the treatment of patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Vericel is marketing MACI^® (autologous cultured chondrocytes on porcine collagen membrane), an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Vericel is also marketing Epicel^® (cultured epidermal autografts), a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. Vericel is developing ixmyelocel-T, an autologous multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy. For more information, please visit the company’s website at www.vcel.com.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, intended product development, clinical activity timing, regulatory progress, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with competitive developments, clinical trial and product development activities, regulatory approval requirements, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, our ability to secure consistent reimbursement for our products, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission (“SEC”) on March 13, 2017, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.

VERICEL CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited, amounts in thousands)

	June 30,			December 31,
	2017			2016
ASSETS
Current assets:
Cash	$	14,041		$	22,978
Accounts receivable (net of allowance for doubtful accounts of $108 and $225, respectively)	14,729			17,093
Inventory	3,155			3,488
Other current assets	1,116			1,164
Total current assets	33,041			44,723
Property and equipment, net	3,493			3,875
Total assets	$	36,534		$	48,598
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	6,272		$	6,535
Accrued expenses	4,135			4,523
Current portion of term loan credit agreement, net of deferred costs of $110	2,112			779
Warrant liabilities	209			757
Other	215			259
Total current liabilities	12,943			12,853
Revolving and term loan credit agreement, net of deferred costs of $238 and $293, respectively	8,040			9,318
Long term deferred rent	1,567			1,687
Other long term debt	11			32
Total liabilities	22,561			23,890
COMMITMENTS AND CONTINGENCIES
Shareholders’ equity:
Series B-2 voting convertible preferred stock, no par value: shares authorized and reserved — 39, shares issued and outstanding — 0 and 12, respectively	—			38,389
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 32,768 and 31,595, respectively	369,540			329,720
Warrants	190			190
Accumulated deficit	(355,757		)	(343,591		)
Total shareholders’ equity	13,973			24,708
Total liabilities and shareholders’ equity	$	36,534		$	48,598

VERICEL CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited, amounts in thousands except per share amounts)

	Three Months Ended June 30,						Six Months Ended June 30,
	2017			2016			2017			2016
Product sales, net	$	16,953		$	12,823		$	26,314		$	26,931
Cost of product sales	7,670			7,300			14,779			13,860
Gross profit	9,283			5,523			11,535			13,071
Research and development	2,971			4,058			6,438			7,594
Selling, general and administrative	8,833			6,449			17,241			12,453
Total operating expenses	11,804			10,507			23,679			20,047
Loss from operations	(2,521		)	(4,984		)	(12,144		)	(6,976		)
Other income (expense):							0
Decrease in fair value of warrants	441			1,942			548			302
Foreign currency translation loss	(13		)	(1		)	(14		)	(11		)
Interest income	3			2			4			7
Interest expense	(299		)	(3		)	(561		)	(6		)
Other income (expense)	1			—			1			(10		)
Total other income (expense)	133			1,940			(22		)	282
Net loss	$	(2,388	)	$	(3,044	)	$	(12,166	)	$	(6,694	)

Net loss per share attributable to common shareholders (Basic and Diluted)	$	(0.07	)	$	(0.22	)	$	(0.38	)	$	(0.46	)
Weighted average number of common shares outstanding (Basic and Diluted)	32,765			22,684			32,333			22,644

Global Media Contacts:
David Schull
Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)
David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)
Karen.chase@russopartnersllc.com

Investor Contacts: 
Chad Rubin
The Trout Group
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
The Trout Group
lstern@troutgroup.com
+1 (646) 378-2922

Histogenics Corporation Announces Second Quarter 2017 Financial and Operating Results

Posted On August 10, 2017 By OrthoSpineNews In Financial /

WALTHAM, Mass., Aug. 10, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced its financial and operational results for the quarter ended June 30, 2017.

“We achieved a significant milestone in the second quarter of 2017 when we completed enrollment of the NeoCart Phase 3 clinical trial with a record 17 patients in the month of June and 30 patients for the quarter. Furthermore, we continue to receive positive feedback from our surgeons regarding the ease of the NeoCart procedure and the potential early pain and functional relief,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “The small lesion microfracture market continues to be underserved and our recent market research in Japan and the United States indicates a product like NeoCart, if approved, could have a meaningful impact in the market as both physicians and patients are seeking novel alternatives to treat cartilage defects. We look forward to the results from our Phase 3 study in the third quarter of 2018, and believe our robust dual threshold responder protocol, along with our one-year endpoint, may provide clear evidence of the potential for NeoCart to replace microfracture as the standard of care for these small lesions.”

Second Quarter 2017 and Recent Highlights

NeoCart Phase 3 Clinical Trial Enrollment Complete: As of June 30, 2017, Histogenics enrolled a total of 249 patients, including 30 patients in the second quarter of 2017 and 17 patients in the month of June 2017. The Phase 3 clinical trial is being conducted under a Special Protocol Assessment (SPA) with the United States Food and Drug Administration (FDA) and Histogenics expects to report top-line data from the trial in the third quarter of 2018 and file a Biologics License Application (BLA) with the FDA in the same quarter, with potential commercialization, if approved, in the second half of 2019.
Identification of Japanese Regulatory Approval Pathway for NeoCart: Histogenics reached agreement with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) regarding the required regulatory pathway for NeoCart in Japan. Due to the quality, breadth and depth of the NeoCart data package, the PMDA agreed that the only additional clinical data required for full Marketing Authorization would be a small 30-patient, one-year confirmatory clinical trial in Japanese patients that compares NeoCart to microfracture. The data from this trial and the one-year U.S. Phase 3 clinical trial data for NeoCart would be appropriate for submission to and potential approval by the PMDA. The PMDA also agreed with Histogenics’ proposal to manufacture NeoCart implants for the Japanese clinical trial at its facility in Waltham, Massachusetts. Histogenics continues to explore partnership opportunities with biotechnology and pharmaceutical companies to complete the limited clinical development required to gain full marketing authorization and commercialize NeoCart in Japan.
U.S. and Japan NeoCart Market Potential: Histogenics recently conducted primary market research in both the U.S. and Japan with almost 200 orthopedic and sports medicine surgeons across both markets. The findings provide support for Histogenics’ assumptions regarding the size of each market and confirm the need in both markets for a novel cartilage repair therapy that will serve as an alternative to microfracture by potentially offering patients a more rapid recovery from pain and return to function as well as a durable treatment response. The results also showed a strong willingness to use a new therapeutic alternative with the characteristics of NeoCart, based on the data from Histogenics completed and ongoing clinical trials. In the U.S., Histogenics is targeting the 150,000 to 200,000 patients receiving microfracture each year, out of the estimated 600,000 procedures annually to treat cartilage defects. Similarly, in Japan there are an estimated 200,000 procedures annually for patients suffering from pain associated with cartilage defects in the knee.
Development of NeoCart Clinical Data and Related Publications: Histogenics continues to work with its university research collaborators on research and development activities. In the second quarter of 2017, data from a collagen and chondrocyte 3-D bioprinting study were published. Histogenics believes that these data can be used to support both process optimization for NeoCart and the NeoCart BLA filing, as well as for the future development of additional product candidates based on the NeoCart platform. Histogenics has also continued its work with Intrexon Corporation (Intrexon) to develop next-generation allogeneic products to treat cartilage defects. The companies have generated exciting proof-of-concept data by combining Intrexon’s induced Pluripotent Stem Cell (iPSC) technology and Histogenics’ NeoCart platform to manufacture next generation, NeoCart implants using iPSC-derived chondrocytes. These implants exhibited similar critical biomarkers of cartilage production and biomechanical data of both native cartilage and the current generation of NeoCart implants. The companies seek to publish the data in 2018.
Enhancement of Executive Team: In the second quarter of 2017, Histogenics appointed Donald Haut, Ph.D. as Chief Business Officer. Dr. Haut has primary responsibility for Histogenics’ commercial licensing discussions in Japan and other regions outside of the United States, commercial and product development strategies and all alliance management and business development activities. Dr. Haut has extensive experience in corporate strategy, business development and licensing, and sales and marketing.

Financial Results for the Second Quarter of 2017

Loss from operations was $(6.4) million in the second quarter of 2017, compared to $(8.0) million in the second quarter of 2016. The decrease in operating expenses was primarily driven by a reduction in research and development expenses.

Research and development expenses were $4.2 million in the second quarter of 2017, compared to $5.8 million in the second quarter of 2016. The decrease was primarily due to reductions in collaboration, consulting and temporary labor costs as well as salary and patient recruitment costs and was partially offset by a small increase in sponsored research expenses with institutions, including Cornell University and Brigham and Women’s Hospital. General and administrative expenses were $2.2 million in the second quarter of 2017, compared to $2.2 million in the second quarter of 2016. An increase in facility related costs was offset by a decrease in stock-based compensation expense.

Net loss attributable to common stockholders was $(5.5) million in the second quarter of 2017, or $(0.25) per share, compared to $(8.0) million, or $(0.61) per share, in the second quarter of 2016. The decrease in net loss attributable to common stockholders is primarily due to lower operating expenses and the allocation of a portion of the net loss to the Series A Preferred Stock.

As of June 30, 2017, Histogenics had cash, cash equivalents and marketable securities of $18.5 million, compared to $31.9 million at December 31, 2016. Histogenics believes its current cash position will be sufficient to fund its operations into the middle of 2018.

Conference Call and Webcast Information

Histogenics’ management will host a conference call on Thursday, August 10, 2017 at 8:30 a.m. EDT. A question-and-answer session will follow Histogenics’ remarks. To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID “37210066” five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the “Investor Relations” page of the Histogenics website, www.histogenics.com. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics is a leading regenerative medicine company developing and commercializing novel tissue therapies that may offer more rapid and durable recoveries for patients with pain and loss of function due to musculoskeletal conditions. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering and bioadhesives to create tissue ex-vivo. Histogenics’ first investigational product candidate, NeoCart is designed to treat cartilage defects in the knee. The Company recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line data in the third quarter of 2018. NeoCart is designed to exhibit characteristics of articular, hyaline cartilage prior to and upon implantation into the knee and therefore does not rely on the body to make new cartilage. As a result, NeoCart is the only product in development or on the market with a one-year primary superiority endpoint as compared to the standard of care. There are more than 500,000 or more knee cartilage procedures in the United States each year, with many healthy active adults avoiding treatment as they seek other alternatives. Left untreated, even a small cartilage defect can expand in size and progress to debilitating osteoarthritis, ultimately necessitating a joint replacement procedure. Osteoarthritis is more common in adults over the age of 50, but the condition and precursors of the condition can be observed much earlier, and cartilage damage is believed to be one of the leading contributors of this disease. For more information, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial; possible delays in releasing the top-line data for the NeoCart Phase 3 clinical trial and timing of filing a BLA; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; Histogenics’ ability to secure a development and commercialization partner for NeoCart in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, which are on file with the Securities and Exchange Commission (the “SEC”) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2017, to be filed with the SEC in the third quarter of 2017. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.


HISTOGENICS CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except share and per share data)

		Three Months Ended June 30,						Six Months Ended June 30,
			2017			2016			2017			2016
Revenue		$	‒		$	‒		$	‒		$	‒

Operating expenses:
	Research and development		4,208			5,794			8,712			11,380
	General and administrative		2,166			2,161			4,492			4,373
Total operating expenses			6,374			7,955			13,204			15,753
Loss from operations			(6,374	)		(7,955	)		(13,204	)		(15,753	)

Other income (expense):
	Interest income (expense), net		40			(17	)		75			(36	)
	Other expense, net		(73	)		(66	)		(90	)		(167	)
	Change in fair value of warrant liability		(135	)		‒			(404	)		‒
Total other (expense), net			(168	)		(83	)		(419	)		(203	)
Net loss		$	(6,542	)	$	(8,038	)	$	(13,623	)	$	(15,956	)

Other comprehensive loss:
	Unrealized gain (loss) from available for sale securities		4			‒			(2	)		‒
Comprehensive Loss		$	(6,538	)	$	(8,038	)	$	(13,625	)	$	(15,956	)

Net Loss attributable to common stockholders – basic and diluted		$	(5,454	)	$	(8,038	)	$	(11,285	)	$	(15,956	)

Net Loss per common share – basic and diluted:		$	(0.25	)	$	(0.61	)	$	(0.51	)	$	(1.20	)
Weighted-average shares used to compute loss per common share – basic and diluted:			22,183,804			13,270,433			22,050,572			13,270,531

HISTOGENICS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share and per share data)

		June 30,		December 31,
		2017		2016


	Cash and cash equivalents and marketable securities	$	18,540	$	31,908
	Prepaid expenses and other current assets		304		173
	Property and equipment, net		3,146		3,860
	Other assets, net		137		137
	Total assets	$	22,127	$	36,078

	Current liabilities	$	3,827	$	5,171
	Warrant and other non-current liabilities		17,494		17,340
	Total stockholder’s equity		806		13,567
	Total liabilities and stockholders’ equity	$	22,127	$	36,078

DJO Global Announces Financial Results for Second Quarter 2017

Posted On August 10, 2017 By OrthoSpineNews In Financial /

August 10, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the second quarter ended July 1, 2017.

Second Quarter Financial Highlights

Net sales grew 0.6% to $294.7 million, or 2.3% on a sales-per-day, constant currency basis.
Net loss attributable to DJOFL was $34.4 million compared to $23.3 million in the prior year period.
Adjusted EBITDA was $63.5 million.

Business Transformation Progress

Significant investments were made, as planned, in the Company’s transformation which remains on track to deliver 7% to 10% annual cost reduction by the end of 2018.
Transformation actions taken to date expected to contribute $15 million in annual savings over the next four quarters.

“Our results for the second quarter, and for the first half, of the year are ahead of our annual operating plan and reflect the hard work our team has contributed to growing the business while transforming our operations,” said Brady Shirley, DJO’s President and Chief Executive Officer. “Over the first half of 2017, we continued to grow our global business and we grew Adjusted EBITDA faster than revenue. We also continued to execute on our business transformation, making investments and taking actions that support our priorities of improved profitability, liquidity, growth and customer experience. Looking forward, we remain confident in both our transformation and the team that we have in place to deliver long-term value to our customers, employees and investors.”

Sales Results

DJOFL achieved net sales for the second quarter of 2017 of $294.7 million, reflecting growth of 0.6%, compared with net sales of $292.9 million for the second quarter of 2016. The second quarter of 2017 included 61 shipping days for our international business compared to 63 for the same period in 2016, while domestic shipping days remained constant at 64 for both the second quarter of 2017 and 2016. Sales in the second quarter of 2017 grew 2.3% on a sales-per-day, constant currency basis over sales in the second quarter of 2016. For the six months ending July 1, 2017, sales grew 2.0% to $583.1 million over the same period in 2016, or 2.7% on a constant currency basis.

Net sales for the Surgical Implant segment grew 17.4% in the second quarter of 2017 to $50.0 million. Sales across all three implant subcategories (knee, hip and shoulder) again grew at double digit rates compared to the prior year. For the six months ending July 1, 2017, Surgical Implant sales grew 16.3%, over the comparable period in 2016, to $99.6 million.

Net sales for DJO’s International segment were $79.6 million in the second quarter of 2017, a decline of 0.6% compared to the second quarter of 2016. On the basis of constant currency and taking into account 61 shipping days for our international business compared to 63 in the prior year, International sales grew 5.3% driven by stronger sales in the Company’s direct markets, primarily Australia, France and Spain, as well as continued growth in the Company’s export markets. For the six months ending July 1, 2017, International sales grew 1.7% to $157.8 million, or 4.3% on a constant currency basis over the comparable period in 2016.

Net sales for DJO’s Recovery Sciences segment were $38.8 million in the second quarter of 2017, reflecting growth of 0.8% compared to the second quarter of 2016. Growth in both of the segment’s major product lines, Chattanooga rehabilitation equipment and Regeneration CMF, was relatively flat in the quarter compared to the prior year period. For the six months ending July 1, 2017, Recovery Sciences sales grew 3.0% to $77.3 million.

Net sales for DJO’s Bracing and Vascular segment were $126.4 million in the second quarter of 2017, a decline of 4.1%, compared to the second quarter of 2016, reflecting general softness across the Company’s bracing and support products, as well as continued pressure in the Company’s Dr. Comfort product line. For the six months ending July 1, 2017, Bracing and Vascular sales declined 2.9% to $248.5 million.

Earnings Results

For the second quarter of 2017, DJOFL reported a net loss of $34.4 million compared to a net loss of $23.3 million for the second quarter of 2016. As detailed in the attached financial tables, the results for the current and prior year second quarter periods and the current and prior year twelve-month periods were impacted by significant non-cash items, non-recurring items and other adjustments.

Adjusted EBITDA for the second quarter of 2017 was $63.5 million compared with Adjusted EBITDA of $63.6 million in the second quarter of 2016. Adjusted EBITDA for the first six months of 2017 was $120.8 million compared with Adjusted EBITDA of $112.5 million in the first six months of 2016. Including projected future savings from cost savings programs currently underway of $15.0 million as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended July 1, 2017 was $258.6 million.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Net cash provided by continuing operating activities for the six months ending July 1, 2017 was $38.1 million compared to a net use of cash of $10.6 million for the same period of 2016. The improvement in cash flow was primarily attributable to working capital initiatives executed as part of the Company’s overall business transformation.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:30 pm, Eastern Time, Thursday, August 10, 2017. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (706) 643-6833), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos™. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payors; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 15, 2017. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.


DJO Finance LLC Unaudited Condensed Consolidated Statements of Operations (In thousands)

	Three Months Ended						Six Months Ended
	July 1, 2017			July 1, 2016			July 1, 2017			July 1, 2016
Net sales	$	294,746		$	292,852		$	583,135		$	571,758
Operating expenses:
Cost of sales (exclusive of amortization, see note 1)		124,885			120,474			244,454			238,557
Selling, general and administrative		135,739			121,627			269,901			243,556
Research and development		9,063			10,122			18,202			19,976
Amortization of intangible assets		16,016			19,085			34,861			38,663
		285,703			271,308			567,418			540,752
Operating income		9,043			21,544			15,717			31,006
Other (expense) income:
Interest expense, net		(43,068	)		(42,396	)		(85,755	)		(84,666	)
Other income, net		896			468			1,184			752
		(42,172	)		(41,928	)		(84,571	)		(83,914	)
Loss before income taxes		(33,129	)		(20,384	)		(68,854	)		(52,908	)
Income tax provision		(1,095	)		(3,577	)		(5,173	)		(8,990	)
Net loss from continuing operations		(34,224	)		(23,961	)		(74,027	)		(61,898	)
Net income from discontinued operations		47			855			105			665
Net loss		(34,177	)		(23,106	)		(73,922	)		(61,233	)
Net income attributable to noncontrolling interests		(206	)		(169	)		(430	)		(362	)
Net loss attributable to DJO Finance LLC	$	(34,383	)	$	(23,275	)	$	(74,352	)	$	(61,595	)

Note 1 — Cost of sales is exclusive of amortization of intangible assets of $6,980 and $13,961 for the three and six months ended July 1, 2017, and $7,080 and $14,487 for the three and six months ended July 1, 2016, respectively.


DJO Finance LLC Unaudited Condensed Consolidated Balance Sheets (In thousands)

	July 1, 2017			December 31, 2016
Assets
Current assets:
Cash and cash equivalents	$	35,197		$	35,212
Accounts receivable, net		170,057			178,193
Inventories, net		148,585			151,557
Prepaid expenses and other current assets		21,300			23,650
Current assets of discontinued operations		511			511
Total current assets		375,650			389,123
Property and equipment, net		133,889			128,019
Goodwill		860,597			855,626
Intangible assets, net		637,989			672,134
Other assets		5,137			5,536
Total assets	$	2,013,262		$	2,050,438
Liabilities and Deficit
Current liabilities:
Accounts payable	$	93,514		$	63,822
Accrued interest		12,934			16,740
Current portion of debt obligations		12,557			10,550
Other current liabilities		124,227			113,265
Total current liabilities		243,232			204,377
Long-term debt obligations		2,381,701			2,392,238
Deferred tax liabilities, net		208,213			202,740
Other long-term liabilities		15,744			14,932
Total liabilities	$	2,848,890		$	2,814,287
Commitments and contingencies
Deficit:
DJO Finance LLC membership deficit:
Member capital		841,424			844,294
Accumulated deficit		(1,653,994	)		(1,579,642	)
Accumulated other comprehensive loss		(24,622	)		(30,580	)
Total membership deficit		(837,192	)		(765,928	)
Noncontrolling interests		1,564			2,079
Total deficit		(835,628	)		(763,849	)
Total liabilities and deficit	$	2,013,262		$	2,050,438


DJO Finance LLC Unaudited Segment Information (In thousands)

	Three Months Ended						Six Months Ended
	July 1, 2017			July 1, 2016			July 1, 2017			July 1, 2016
Net sales:
Bracing and Vascular	$	126,415		$	131,751		$	248,468		$	255,967
Recovery Sciences		38,774			38,449			77,277			75,024
Surgical Implant		49,991			42,575			99,583			85,625
International		79,566			80,077			157,807			155,142
	$	294,746		$	292,852		$	583,135		$	571,758
Operating income:
Bracing and Vascular	$	24,225		$	29,072		$	45,232		$	49,606
Recovery Sciences		10,709			8,056			19,616			14,501
Surgical Implant		10,062			6,053			18,202			13,282
International		13,509			14,653			27,119			23,642
Expenses not allocated to segments and eliminations		(49,462	)		(36,290	)		(94,452	)		(70,025	)
	$	9,043		$	21,544		$	15,717		$	31,006

DJO Finance LLC
Adjusted EBITDA

For the Three and Six Months Ended July 1, 2017 and 2016
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,036.5 million term loan facility (including a $20.0 million delayed draw term loan facility) and a $150.0 million asset-based revolving credit facility, under which $68.0 million was outstanding as of July 1, 2017, and the Indentures governing our $1,015.0 million of 8.125% second lien notes and $298.5 million of 10.75% third lien notes (collectively, the “notes”) represent significant components of our capital structure. Under our Senior Secured Credit Facilities, we are required to maintain a specified senior secured first lien leverage ratio, which is determined based on our Adjusted EBITDA. If we fail to comply with the senior secured first lien leverage ratio under our Senior Secured Credit Facilities, we would be in default. Upon the occurrence of an event of default under the Senior Secured Credit Facilities, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facilities to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facilities could proceed against the collateral granted to them to secure that indebtedness. We have pledged substantially all of our assets as collateral under the Senior Secured Credit Facilities and under the notes. Any acceleration under the Senior Secured Credit Facilities would also result in a default under the Indentures governing the notes, which could lead to the note holders electing to declare the principal, premium, if any, and interest on the then outstanding notes immediately due and payable. In addition, under the Indentures governing the notes, our and our subsidiaries’ ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA. Our ability to meet the covenants specified in the Senior Secured Credit Facilities and the Indentures governing those notes will depend on future events, some of which are beyond our control, and we cannot assure you that we will meet those covenants.

Adjusted EBITDA is defined as net income (loss) attributable to DJOFL plus interest expense, net, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance and other ratios under our Senior Secured Credit Facilities and the Indentures governing the notes. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants and other ratios in our Senior Secured Credit Facilities and the Indentures governing the notes. Adjusted EBITDA is a material component of these calculations.

Adjusted EBITDA should not be considered as an alternative to net income (loss) attributable to DJOFL or other performance measures presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) attributable to DJOFL or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA under our Senior Secured Credit Facilities and the Indentures governing the notes allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net income (loss) attributable to DJOFL. However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

The following table provides reconciliation between net loss attributable to DJOFL and Adjusted EBITDA (in thousands):

													Twelve
													Months
	Three Months Ended						Six Months Ended						Ended
	July 1,			July 1,			July 1,			July 1,			July 1,
	2017			2016			2017			2016			2017
Net loss attributable to DJO Finance LLC	$	(34,383	)	$	(23,275	)	$	(74,352	)	$	(61,595	)	$	(299,060	)
Income from discontinued operations, net		(47	)		(855	)		(105	)		(665	)		(579	)
Interest expense, net		43,068			42,396			85,755			84,666			171,168
Income tax provision (benefit)		1,095			3,577			5,173			8,990			(10,669	)
Depreciation and amortization		26,942			29,274			56,716			59,176			115,432
Non-cash charges (a)		537			2,204			1,108			2,603			180,904
Non-recurring and integration charges (b)		25,195			8,605			43,584			15,937			76,322
Other adjustment items (c)		1,142			1,636			2,911			3,366			10,102
		63,549			63,562			120,790			112,478			243,620
Permitted pro forma adjustments applicable to the twelve month period only (d)
Future cost savings														14,988
Adjusted EBITDA	$	63,549		$	63,562		$	120,790		$	112,478		$	258,608

(a)	Non-cash charges are comprised of the following:

											Twelve
											Months
			Three Months Ended				Six Months Ended				Ended
			July 1,		July 1,		July 1,		July 1,		July 1,
			2017		2016		2017		2016		2017
		Stock compensation expense	$	392	$	1,316	$	846	$	1,521	$	2,513
		Loss on disposal of fixed assets and assets held for sale, net		145		783		262		890		321
		Impairment of goodwill (1)		—		—		—		—		160,000
		Inventory adjustments (2)		—		—		—		—		18,013
		Purchase accounting adjustments (3)		—		105		—		192		57
		Total non-cash charges	$	537	$	2,204	$	1,108	$	2,603	$	180,904

						(1)			Impairment of goodwill and intangible assets for the twelve months ended July 1, 2017 consisted of goodwill impairment charges of $99.0 million and $61.0 million related to the CMF and Vascular reporting units, respectively. The impairment charge for our CMF reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to disruption caused by our exit of the Empi business. The impairment charge for our Vascular reporting unit resulted from reductions in our projected operating results and estimated future cash flows due to a loss of revenue caused by disruption as we transitioned our Dr. Comfort therapeutic footwear manufacturing and distribution to a new ERP system and market pressure in the therapeutic shoe market.
						(2)			In the fourth quarter of fiscal 2016, current management implemented a new strategy relating to our procurement, manufacturing and liquidation philosophies in order to significantly reduce inventory levels. Historically, our strategy was to purchase inventory in large quantities to capture purchase discounts and rebates and provide an expansive mix of products for our customers. Our new strategy aims to integrate our supply chain services with customer demand through focused forecasted consumption and sales efforts, therefore limiting the range of SKUs we plan to offer. As a result of these changes, the Company recorded a charge to cost of sales and corresponding reduction in inventory of approximately $18.0 million. The E&O reserve expense in fiscal 2016 included $5.7 million related to the Company’s decision to discontinue certain SKUs mainly within the Bracing and Vascular product lines, $8.3 million related to holding inventory for shorter periods and the planned scrapping of long-dated inventory, $2.0 million related to new Surgical Implant products that changed the expected life cycle of its current product portfolio, and $2.0 million of slow moving consigned inventory within certain OfficeCare clinics for which management has decided not to strategically relocate.
						(3)			Purchase accounting adjustments consisted of amortization of fair market value inventory adjustments for all periods presented.

(b)	Non-recurring and integration charges are comprised of the following:

													Twelve
													Months
			Three Months Ended					Six Months Ended					Ended
			July 1,			July 1,		July 1,			July 1,		July 1,
			2017			2016		2017			2016		2017
		Restructuring and reorganization	$	23,273		$	1,476	$	39,069		$	3,469	$	52,478
		Acquisition related expenses and integration (1)		277			2,657		579			5,982		4,947
		Executive transition		(49	)		—		(49	)		—		4,767
		Litigation and regulatory costs and settlements, net (2)		1,290			4,472		3,392			6,486		13,468
		IT automation projects		404			—		593			—		662
		Total non-recurring and integration charges	$	25,195		$	8,605	$	43,584		$	15,937	$	76,322

						(1)			Consists of direct acquisition costs and integration expenses related to acquired businesses and costs related to potential acquisitions.
						(2)			For the twelve months ended July 1, 2017, litigation and regulatory costs consisted of $1.4 million in litigation costs related to ongoing product liability issues and $12.1 million related to other litigation and regulatory costs and settlements.

(c)	Other adjustment items are comprised of the following:

															Twelve
															Months
			Three Months Ended						Six Months Ended						Ended
			July 1,			July 1,			July 1,			July 1,			July 1,
			2017			2016			2017			2016			2017
		Blackstone monitoring fees	$	1,750		$	1,750		$	3,500		$	3,500		$	7,000
		Noncontrolling interests		206			169			430			362			691
		Other (1)		(814	)		(283	)		(1,019	)		(496	)		2,411
		Total other adjustment items	$	1,142		$	1,636		$	2,911		$	3,366		$	10,102

						(1)			Other adjustments consist primarily of net realized and unrealized foreign currency transaction gains and losses.

(d)			Permitted pro forma adjustments include future cost savings related to the exit of our Empi business and our business transformation initiative.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
(760) 734-3075
ir@djoglobal.com

Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications

Posted On August 10, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

BELGRADE, Mont., Aug. 09, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced that the U.S. Food and Drug Administration (FDA) has cleared product line extensions for the Calix-C family of cervical interbody cages. The clearance provides for the addition of two larger footprints and importantly, for use with allograft. This clearance strengthens Xtant Medical’s focus in regenerative technologies, providing a more comprehensive. integrated cervical treatment option for surgeons and their patients.

In Xtant’s continued effort to combine our hardware and biologics products to provide total solutions for our customers, the Calix-C indication now includes use with allograft comprised of cancellous and/or corticocancellous bone graft in addition to the current use with autograft. Xtant Medical’s 3Demin and patented OsteoSponge technology are ideal allografts to use with Calix-C due to their ability to compress, fill and expand within the interbody’s graft chamber, allowing for ideal bone contact with the vertebral plates and fusion. OsteoVive, a cellular allograft, can also be used in conjunction with Calix-C. The additional, larger footprints of Calix-C are designed for increased stability against the vertebral endplates, and allow for a larger lumen for bone graft, making it a better surgical option for a greater number of patients. The addition of the allograft indication and the larger sizes will all be available in PEEK and Titanium plasma coated PEEK.

“This new FDA clearance allows Xtant Medical to leverage the clinical effectiveness of our established allograft product offerings for use with our now expanded line of interbody devices in cervical discectomy and fusion procedures” stated Dr. Gregory Juda, CSO and GM of Xtant Medical. “We expect that the use of these products as a combined spinal fusion solution will result in positive patient outcomes.”

The Calix‐C™ Cervical Interbody Spacer is intended for spinal fusion procedures at one level (C2 – T1 inclusive) in skeletally mature patients and is intended to be used with supplemental spinal fixation systems such as Xtant Medical’s Spider Cervical Plating and Certex Spinal Fixation Systems.

Xtant Medical estimates the worldwide market for cervical fusion devices at $1.3B and growing. The worldwide market for Demineralized Bone Matrix (DBM) is estimated at $485M. The Company has initiated collaborative marketing efforts for the current Calix-C offering with the surgeon’s preferred Xtant Medical allograft, and is preparing for the alpha launch of the new Calix-C sizes later this year.

About Xtant Medical

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE MKT; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact

CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact

Xtant Medical
Molly Mason
mmason@xtantmedical.com

Hip Innovation Technology Initiates Clinical Trial of its Novel Hip Replacement System for the Treatment of Total Hip Arthroplasty

Posted On August 10, 2017 By OrthoSpineNews In Recon, Top Stories /

BOCA RATON, Fla., Aug. 9, 2017 /PRNewswire/ — Hip Innovation Technology, LLC (HIT), a medical device company developing innovative orthopedic device solutions to advance the quality of life and quality of care for patients, today announces the initiation of a Multi-Center Prospective Study in Primary Total Hip Arthroplasty for its lead hip replacement system, the HRS. Total hip arthroplasty is commonly referred to as total hip replacement.

The objective of the clinical trial is to evaluate the effectiveness and safety of the HRS hip replacement system in 100 – 120 patients receiving a total hip arthroplasty (THA). Effectiveness will be evaluated using clinical, radiologic, radiostereometric and patient-reported outcomes. Safety will be assessed through the collection of device-related adverse events. Patient quality of life metrics will also be closely monitored.

“The HRS is a unique hip implant design that we believe represents breakthrough technology and a significant advancement for patients requiring total hip arthroplasty,” said George Diamantoni, Hip Innovation Technology’s Co-Founder and Chief Executive Officer. “We look forward to confirming potential differentiating clinical benefits including hip stability at extended ranges of motion, reduced risk of device dislocation and greater latitude for placement of hip components relative to the current designs.”

The company has extensively tested the HRS in over 80 standard and unique pre-clinical experiments to assess the product safety and clinical benefits anticipated by the unique system design.

“The bench level data compiled for the HRS is more extensive than any that I have reviewed for currently marketed hip implant systems,” said Thomas Turgeon, MD, Chief Medical Officer of the Orthopaedic Innovation Centre, and Orthopaedic Surgeon at Concordia Joint Replacement Group. “I am impressed with the unique system design. I look forward to assessing its clinical performance, and am hopeful that many patients will benefit from this novel device.”

Total hip replacements are one of the most effective ways to reduce joint pain and improve functioning for patients with advanced hip problems. During the 2015 calendar year, approximately 324,000 surgeries were performed in the U.S. and 50,000 in Canada.

About Hip Innovation Technology, LLC

Headquartered in Boca Raton, Florida, Hip Innovation Technology was formed in 2011 to provide market-leading orthopedic device solutions that advance the quality of life and quality of care for patients. In partnership with healthcare professionals worldwide, our goal is to identify unmet clinical need, then design, manufacture and ultimately market innovative orthopedic reconstructive and related surgical product solutions.

About the HRS

The HRS is a Metal-on-Polyethylene reverse geometry hip prosthesis designed to improve stability at extended ranges of motion and reduce the risk of dislocation. Like most conventional systems, the HRS consists of a femoral stem, an acetabular cup and a cobalt-chrome ball that articulates within a polyethylene liner. Unlike other systems, the ball sits on the acetabular cup instead of the femoral stem, and the polyethylene liner is attached to a femoral cup, which attaches to the femoral stem, instead of the polyethylene liner being attached to the acetabular cup. Despite this technological difference, the center of rotation of the HRS is similar to a normal physiological hip or a well-positioned Total Hip Arthroplasty. The advanced HRS implant design may provide greater range of motion in all planes with enhanced hip stability while significantly minimizing the risk of dislocation. In addition, the HRS may provide minimal postoperative restrictions and reduce the need for currently required durable medical equipment such as abduction pillows, elevated toilet seats and shower chairs. Importantly, the HRS also provides variability of component placement including higher abduction angles and anteversion of the acetabular cup. The femoral cup articulates around the acetabular ball and overlaps with the acetabular cup as the hip undergoes flexion-extension, abduction-adduction and internal-external rotation. This forgiving design compensates for suboptimal component positioning which likely provides benefits such as extended range of motion, hip stability and reduced likelihood of impingement. Simply stated, the HRS appears to uncouple the relationship between component placement, wear and stability. The unique implant design of the HRS provides optimal surface area contact between the acetabular ball and femoral cup, which may eliminate edge loading. Elimination of edge loading may provide benefits that include reduced high-contact stresses, decreased implant wear and uniform wear, which minimizes generation of wear debris and associated concerns related to osteolysis.

For more information, visit www.hipinnovationtechnology.com.

Cautionary Statement Regarding Forward-Looking Statements
This news release may contain forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Hip Innovation Technology’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. Hip Innovation Technology disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.

Contact:
George Diamantoni, CEO
Hip Innovation Technology
InvestorRelations@HIT-IRH.com

Media:
Kara Golub
JFK Communications, Inc.
(609) 456-0822
kgolub@jfkhealth.com

SOURCE Hip Innovation Technology, LLC

SI-BONE, Inc. Announces Publication of a Level I Study Demonstrating Strong Clinical Prediction for the Diagnosis of SI Joint Dysfunction

Posted On August 10, 2017 By OrthoSpineNews In Spine /

SAN JOSE, Calif., Aug. 9, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System^® (iFuse), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced the publication of a systematic review of diagnostic accuracy studies titled Clinical classification in low back pain: best-evidence diagnostic rules based on systematic reviews¹. The article, published in the journal BMC Musculoskeletal Disorders by Petersen, Laslett and Juhl, is the first comprehensive systematic review of diagnostic accuracy studies. The goal of the study was to develop clinical diagnostic rules for identifying the most common disorders of the lumbar spine. The study reports strong clinical evidence that the SI joint can be diagnosed as a source of low back pain with an acceptable accuracy using 3 of 5 positive provocative maneuvers and the presence of pain localized over the posterior superior iliac spine (PSIS) when other sources of pain have been excluded.

The focus of the review was to outline the diagnostic value of signs and symptoms for use in primary care without access to additional more expensive and invasive confirmatory tests. The intent was to provide an evidence-based clinical diagnosis with acceptable accuracy that may reduce the need for invasive or expensive diagnostic methods. In a primary care setting, the clinical prediction rule for the diagnosis of SI joint pain, using a cluster of 3 of 5 positive provocative maneuvers in the absence of known discogenic or radicular pain, and dominant pain localized over the posterior superior iliac spine (PSIS), are as good or in most cases better than the clinical prediction rules for other lumbar spine conditions.

“The takeaway of this review is that physical exam findings for the SI joint are more predictive of a positive SI joint block than most other physical exam tests for other low back conditions,” said Mark Laslett, PhD, one of the study authors. “While controlled and guided intra-articular SI joint blocks are the best reference standard test for intra-articular SI joint pain, positive provocation SI joint tests in patients known to have no other obvious source of pain, is a reliable and validated diagnostic process that primary care clinicians can predicate referral for surgical opinion and more invasive diagnostic workup.”

About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain^2-5, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.⁶ Patients with SI joint disorders may feel pain in the lower back, buttocks and/or legs localized over the posterior superior iliac spine (PSIS). This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.

SI joint pain is often misdiagnosed or misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it. SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test. The diagnosis is confirmed with an appropriate physical examination and image-guided diagnostic injections directly in the SI joint.

About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum. The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint’s unique motion of nutation. The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth⁷, facilitating long-term fusion of the joint. The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.

The iFuse Implant System^® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months. There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For information about the risks, visit: www.si-bone.com/risks

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders. SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.

Petersen, et al. Clinical classification in low back pain: best-evidence diagnostic rules based on systematic reviews. BMC Musculoskeletal Disorders. 2017; 18:188
Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.
MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.

SOURCE SI-BONE, Inc.

ConforMIS Acquires Machining and Polishing Assets from Broad Peak Manufacturing

Posted On August 10, 2017 By OrthoSpineNews In Financial, Top Stories /

BILLERICA, Mass., Aug. 09, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that offers joint replacement implants customized to fit each patient’s unique anatomy, today announced that it has acquired the machining and polishing assets of Broad Peak Manufacturing, LLC, a high-precision surface preparation and finishing facility. The purchase price for the machining and polishing assets is approximately $6.5 million consisting of $5.75 million in cash and approximately $0.75 million in common stock. Under the terms of the deal, ConforMIS will integrate most of the Broad Peak employees, acquire supplies and equipment, and lease a fully operational manufacturing facility and office space in Wallingford, Connecticut.

Broad Peak has provided polishing services for ConforMIS’ femoral implant component including iTotal® CR, iTotal® PS, iUni® and iDuo® since 2014. Starting in the first quarter of 2018, ConforMIS estimates that the integration of the Broad Peak polishing operations will result in a reduction in the cost of polishing of up to 50%, and potentially more, with a potential 200 basis point improvement in overall gross margin.

“This acquisition represents an important step in enhancing the manufacturing of our customized knee implants,” said Mark Augusti, Chief Executive Officer and President of ConforMIS. “Our goal is to continuously invest in specific areas of our business that will improve overall operational efficiencies while maintaining our commitment to quality product for our patients. Integrating Broad Peak’s proven and innovative manufacturing operation directly into ConforMIS’ operations will allow us to further reduce costs, improve gross margin, and add additional manufacturing expertise that we intend to leverage as part of our larger plan to continually improve our manufacturing operations and our gross margin.”

Under the terms of the agreement, ConforMIS will lease the manufacturing facility in Wallingford, CT, and approximately twenty Broad Peak machining and polishing personnel will join the ConforMIS team, including Ed Kilgallen, former Managing Director at Broad Peak, who has joined ConforMIS as its Vice President of Operations.

“As a highly proficient supplier of polishing services to ConforMIS, Broad Peak has a combined 70+ years’ experience in the aerospace and medical device industries, and we are extremely excited about our new role as part of the ConforMIS team,” said Mr. Kilgallen. “We look forward to playing an even larger role in the development of ConforMIS’ manufacturing technology and to continuing to help deliver high-quality customized knee implants to patients, surgeons and hospitals globally.”

“We anticipate that the integration of Broad Peak’s polishing resources and expertise will deliver rapid and potentially immediate benefits to ConforMIS,” Mr. Augusti added. “As we work to maximize the value of our existing customized knee implant systems and our planned iTotal Hip system, this transaction is just one example of the positive steps we are taking to continually improve every phase of our business.”

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

About Broad Peak Manufacturing, LLC

Broad Peak is a high-precision femoral finishing facility strategically located less than 100 miles from both NY Metro and Boston. Broad Peak is an ISO 9001:2008 & 13485:2003 accredited facility, providing surface enhancement solutions to a variety of femoral components. The core team at Broad Peak has a long history with femoral manufacturing stretching back to 1998. Broad Peak has provided a multitude of services to medical OEM facilities in Europe, Asia and North America including, but not limited to, Contract Manufacturing, VMI, Contract Inspection, Packaging, as well as validated Manufacturing Cell Transfers and the suite of required SPPAP documentation. Broad Peak is currently specializing in Patient Specific Femoral machining and finishing. This complex process requires modeling, programming and manufacturing of individual fixtures for these implants in order to process the components to a finished state.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about cost savings associated polishing of implant components, cost savings or other benefits associated with the purchase of Broad Peak assets, gross margin improvement as a result of the any manufacturing plans or gross margin improvement plans, the progress of any manufacturing plans or any gross margin improvement plans, the impact of the purchase of assets of Broad Peak on ConforMIS’ financial results, the development of the iTotal Hip implant system, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our product development and commercialization efforts, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Lynn Granito
Berry & Company Public Relations
lgranito@berrypr.com
(212) 253-8881

Investor Contact:
Oksana Bradley
ir@conformis.com
(781) 374-5598

Nextremity Solutions, Inc. Announces Limited Release of the PiroVue™ Gastrocnemius Recession System

Posted On August 9, 2017 By OrthoSpineNews In Extremities /

WARSAW, Ind., Aug. 8, 2017 /PRNewswire-iReach/ — Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the musculoskeletal space, located in “The Orthopedic Capital of the World” Warsaw, IN, has announced the limited release of its newest product, the PiroVue^TM Gastrocnemius Recession System for the treatment of equinus deformities in patients.

According to a report in the 2015 Podiatry Management publication by Patrick A Deheer, DPM entitled, “The Non-Surgical Treatment of Equinus”, equinus deformity has been associated with over 96% of biomechanically related foot and ankle pathologies. An equinus deformity is a condition that limits the bending motion of the ankle joint. A patient with this deformity lacks the flexibility to raise their foot up and has a tendency to apply too much pressure to the bones in the forefoot. Equinus deformity can contribute to foot problems such as plantar fasciitis, metatarsalgia, arthritis of the midfoot, bunions, hammertoes, and more.”

PiroVue is a disposable, single use, sterile packed instrument kit for gastrocnemius recession. It consists of an integrated cutting guide and retractor with a controlled recession knife.

“We’re excited about the launch of PiroVue, a solution born from the frustration and ingenuity of our surgeons. Our surgeons are passionate about this gastrocnemius recession procedure and the resulting benefits they’ve seen in their patients. This disposable, efficient, and cost-effective solution for gastrocnemius and soleus recession will potentially result in less muscle atrophy and weakness, as well as early weight bearing, relatively shorter periods of cast immobilization, while reducing risks to the sural nerve. Our hope is that PiroVue will allow for continued adoption and growth of this surgical procedure.” commented Ryan S. Schlotterback, Chief Commercialization Officer for Nextremity Solutions, Inc.

The patent-pending PiroVue Gastrocnemius Recession System will utilize a limited launch with key surgeons prior to a full commercial launch in Q1 2018.

Rod K. Mayer, President and CEO of Nextremity added, “Our goal as a part of our i3^TMStrategic Solutions initiative is to continue to workwith surgeons to address their unmet needs in their respective surgical specialties. Our passion for creating innovative product solutions is to positively and significantly impact the lives of patients. If through the PiroVue Gastrocnemius Recession System patients can potentially get them back on their feet sooner with less issues, then we have succeeded.”

For more information or to schedule a demonstration of the PiroVue Gastrocnemius Recession System, please visit http://www.nextremity.com/pirovue.

About Nextremity Solutions, Inc.

Nextremity Solutions, Inc. is a privately held strategic commercialization organization with a focus on the musculoskeletal space, offering innovative solutions and Revenue Ready™ products for various musculoskeletal applications and for the benefit of our industry partners. The Company’s procedure-ready, sterile implant systems include uniquely precise, proprietary technology designed to achieve repeatable and superior clinical outcomes.

For further information, visit www.nextremitysolutions.com or call Dave Temple, Director of Marketing & Corporate Communications at 574-635-3022.

Media Contact: Dave Temple, Nextremity Solutions, Inc., 574-635-3022, dave.temple@nextremity.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Nextremity Solutions, Inc.

MiMedx Hits Milestone of One Million Allografts Distributed

Posted On August 9, 2017 By OrthoSpineNews In Biologics, Top Stories /

MARIETTA, Ga., Aug. 9, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has now distributed over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.

Parker H. “Pete” Petit, Chairman and CEO stated, “We are very pleased about hitting this impressive milestone of supplying our one millionth allograft. We are especially proud of the hundreds of thousands of patients that our allografts have aided in the healing of their respective conditions. The remarkable outcomes produced by the application of our allografts have assisted physicians and their patients in countless areas of care. These include recovery from acute and traumatic wounds that are debilitating and complex; avoidance of limb amputations; supporting various surgical applications to provide a barrier to reduce the amount of scar tissue formation, modulate inflammation and help with the soft tissue healing of the area; and repair and reconstruction of various soft-tissue injuries in or around joints caused by traumas or chronic conditions. The soft tissue injuries treated with our allografts affect various anatomical locations, mainly knee, shoulder, elbow, foot and ankle and hand and wrist injuries, as well as tendinopathies, tendinitis, tendinosis, tendon and ligament sprains, and ruptures.”

Bill Taylor, President and COO, added, “We are also extremely proud of our outstanding safety record. We have extremely stringent screening and quality standards in our recovery of donated placentas, and our patented processing methodology includes both aseptic processing as well as terminal sterilization, which enhances the safety and prevention of infectious disease transmission of our allografts. Moreover, our strict sterilization processes and proprietary processing methodology does not affect the cytokines, growth factors, regulatory proteins, chemokines and other critical factors that optimize the performance of the MiMedx allografts and enable our allografts to deliver the clinical results that Pete just referenced.”

“Our dehydrated human amnion chorion membrane (dHACM) allografts are described in an official United States Pharmacopeia and The National Formulary (USP-NF) Monograph, which sets the standards for drug substances, dosage forms, excipients, compounded preparations, dietary supplements, and medical devices. A USP-NF Monograph on a human tissue product is a very rare occurrence and a recognition that allografts claiming to be dHACM allografts are only those produced in conformance with these exceptionally high standards to avoid any potential for adulteration or misbranding. We are very proud to have that distinction,” added Petit.

“The areas of care that our allografts serve are a major burden on the American health care system in both the negative impact they have on the patient’s quality of life and functionality as well as the escalating costs of care. We are pleased that we have and will continue to play an expanding role in helping the healthcare community resolve these burdens by improving outcomes and reducing costs,” noted Chris Cashman, EVP and Chief Commercialization Officer.

In recognition of this achievement, we will be make a donation to a charity recommended by the physician that utilized our one millionth allograft,” concluded Petit.

About MiMedx
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Month: August 2017

InVivo Therapeutics Announces Exchange of Certain Warrants for Common Stock

Contacts

Vericel Reports Second-Quarter 2017 Financial Results

Histogenics Corporation Announces Second Quarter 2017 Financial and Operating Results

DJO Global Announces Financial Results for Second Quarter 2017

Contacts

Xtant Medical Receives FDA Clearance for Calix-C Cervical Interbody Line Extension and Expanded Indications

Hip Innovation Technology Initiates Clinical Trial of its Novel Hip Replacement System for the Treatment of Total Hip Arthroplasty

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SI-BONE, Inc. Announces Publication of a Level I Study Demonstrating Strong Clinical Prediction for the Diagnosis of SI Joint Dysfunction

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ConforMIS Acquires Machining and Polishing Assets from Broad Peak Manufacturing

Nextremity Solutions, Inc. Announces Limited Release of the PiroVue™ Gastrocnemius Recession System

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MiMedx Hits Milestone of One Million Allografts Distributed

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