VTI Moves Its Headquarters To Upgraded Facility

Posted On February 17, 2017 By OrthoSpineNews In Spine /

MINNEAPOLIS, MINNESOTA (PRWEB) FEBRUARY 16, 2017

Vertebral Technologies, Inc. a MIS spinal implant medical device company based in Minneapolis, MN, has successfully moved their facilities from Minnetonka, MN to Minneapolis, MN. Brian Thron Director of Marketing says “the contemporary space compliments the company’s latest rebrand, with its simplistic design and modern color scheme. I’m pleased to call this space VTI’s new home”.

“VTI’s new ISO Class 8 Controlled Environment is fully operational post the certification and validation testing process. In addition, the new facility allows VTI to take advantage of increased efficiency across multiple departments with a new office layout that encourages collaboration to everyday operations. We are looking forward to these operative advantages moving forward as VTI grows in 2017”. says Director of Manufacturing Brian Holmberg.

President & CEO Matt Kyle stated “We are excited to be in our new space. The VTI team did a tremendous job of executing the move without disruption. The new space helps everyone align with our organizational objectives and growth focused culture. The feedback we have received, both internal and external, has been very positive.”

ABOUT VTI – VERTEBRAL TECHNOLOGIES, INC.
VTI – Vertebral Technologies, Inc. is a privately held company based in Minneapolis, MN, USA. VTI is dedicated to the design, development, manufacturing and marketing of medical devices to address painful conditions of the spine through less-invasive surgical approaches. VTI’s products utilize its unique modular-assembly technology to deliver solutions optimized for both surgeons and their patients. VTI sells its InterFuse® modular interbody fusion devices worldwide.

For more information, visit: http://www.vti-spine.com or contact Brian Thron at marketing(at)vti-spine(dot)com or + 1.877.912.5401.

Medacta Enters Shoulder Surgery Market with Successful First Surgery Using its Medacta Shoulder System

Posted On February 17, 2017 By OrthoSpineNews In Extremities /

February 16, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Building on its success in the hip, knee and spine product areas, family-owned orthopedics leader Medacta International is expanding into the shoulder arthroplasty market. The company today announced the completion of the first surgery utilizing its Medacta Shoulder System, performed by Professor Ralph Hertel in Bern, Switzerland.

“The procedure was a success,” said Professor Hertel, who has specialized in shoulder and elbow surgery for more than two decades. “As expected, the early postoperative phase and hospital stay were uneventful, and the patient is on a smooth path to recovery. We’re very pleased.”

The Medacta Shoulder System is a modular solution that features a broad range of options, including wide-ranging sizes, adjustable offset, innovative configurations and the CT-based MyShoulder 3D preoperative planning solution for patient-specific humeral and glenoid guides.

“With the Medacta Shoulder System, we are entering the fast growing upper extremity market with the same patient-centric vision and ambition that characterized our growth and success in knee, hip and spine technology: delivering innovation through high-level surgical education and providing real benefits to patients and healthcare system sustainability,” said Alberto Siccardi, President and Founder of Medacta International.

Designed by a group of expert surgeons from Europe, Australia and the United States, the Medacta Shoulder System also offers the flexibility to move from a total to reverse arthroplasty without the need to revise all components.

“The most important consideration in orthopedics and joint replacement is not only to improve implant design, but also to elevate design standards. With the Medacta Shoulder System, we aim to solve the issues related to implant design, polyethylene wear and the reproducibility of results,” said Francesco Siccardi, Executive Vice President of Medacta International.

The Medacta Shoulder System is currently under clinical evaluation by the surgeon design team and will be available in 2018.

For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta

Medacta^® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS^®system and total knee replacement with MyKnee^® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

NuVasive Receives 11-Year PILOT, Will Invest $116 Million

Posted On February 17, 2017 By OrthoSpineNews In Financial /

By Patrick Lantrip – Friday, February 17, 2017

Medical device company NuVasive Inc. has been approved for an 11-year tax incentive that will allow them to invest $116 million into their southeast Memphis facility and create 15 net new jobs.

The Economic Development Growth Engine board approved the Jobs PILOT (payment-in-lieu-of-taxes) incentive at its Wednesday, Feb. 15, meeting.

San Diego-based NuVasive plans to spend $115 million on new surgical and computer equipment and $700,000 on renovations to its regional office and distribution center at 4670 E. Shelby Drive. The average salary of the 15 new jobs will be $38,000.

“We always get excited about new projects coming to town,” said EDGE board member Larry Jackson. “But I want us to be just as excited when an existing success story wants to expand in Memphis and Shelby County.”

If NuVasive invests an additional $38 million within four years, for a total capital investment of $155 million, the company will receive a one-year extension on its PILOT.

READ THE REST HERE

Jamaican doctor pioneers disc replacement procedure

Posted On February 16, 2017 By OrthoSpineNews In Spine /

Tuesday, February 14, 2017

A group of doctors has high hopes that an artificial disc, owned exclusively by a Jamaican-born doctor, can be used as a tool to drive medical tourism in Jamaica.

The technology was used for the first time in a four-level disc replacement procedure at the Andrews Memorial Hospital in St Andrew on February 1. The surgical procedure was performed by orthopaedic spinal surgeon Dr Kingsley Chin, who was born in Buff Bay, Portland.

Chin is CEO of KIC Ventures, a venture capital firm focused on the health technology sector and the owner of AxioMed, a health tech company that has developed the technology known as the Freedom Cervical disc. AxioMed was founded to advance the standard of care for patients with degenerative spine conditions and has now successfully developed the artificial disc that most closely mimics the normal disc using viscoelastic polymer technology.

In disc replacement, worn or damaged disc material between the small bones in the spine (vertebrae) is removed and replaced with a synthetic or ‘artificial’ disc. The goal of the procedure is to relieve back pain while maintaining more normal motion than is allowed with some other procedures, such as spinal fusion. The Freedom Cervical disc is said to most closely mimic the natural properties of a healthy human disc and has been proven to withstand the forces and wear of decades of use.

On February 1, Dr Chin operated on a female patient with a prolapsed disc who would’ve been in need of several surgical procedures with sequential disc replacement or a fusion of the discs, which would’ve limited her neck motion.

For the procedure, he worked with his team of University of the West Indies (UWI) and Oxford-trained Rhodes Scholar Dr David Walcott, UWI & Yale-trained neurosurgeon Dr J Geoffrey Liburd, and anesthesiologist Dr Patrick Toppin.

READ THE REST HERE

Aetna, Humana Abandon Merger, Putting Paths to Growth in Doubt

Posted On February 16, 2017 By OrthoSpineNews In Financial /

By ANNA WILDE MATHEWS – Feb. 14, 2017

Aetna Inc. and Humana Inc. won’t appeal a judge’s decision to block their merger on antitrust grounds, avoiding what had been widely seen as an uphill battle to preserve the $34 billion deal.

The health insurers on Tuesday said they will terminate their merger agreement. Immediately after the antitrust decision last month, Aetna had said it would consider appealing, but more recently both companies said they were weighing their options. The end of their deal, which would have forged a diversified insurance powerhouse, leaves both insurers with challenges as they forge separate paths forward.

Aetna, which with the Humana acquisition would have been poised to become the biggest player in the private Medicare coverage known as Medicare Advantage, now has to find new engines of growth. Humana walks away with a $1 billion breakup fee that the insurer has indicated it could put toward share buybacks, dividends and acquisitions, though Humana itself is seen as an attractive takeover target once again.

Broadly, the termination marks a larger unwinding of an insurance-industry merger frenzy in 2015. Both the Aetna-Humana deal and another health-insurance merger between Anthem Inc. and Cigna Corp. were forged then, and the Justice Department challenged both last July. Anthem has said it intends to appeal a judge’s decision to block its deal, but the fate of its acquisition is unclear amid discord between Anthem and Cigna.

In a statement, Aetna Chief Executive Mark T. Bertolini said the insurers were “disappointed to take this course of action after 19 months of planning, but both companies need to move forward with their respective strategies in order to continue to meet member expectations.”

READ THE REST HERE

Anika Reports Fourth Quarter and Full Year 2016 Financial Results

Posted On February 16, 2017 By OrthoSpineNews In Financial /

February 15, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the fourth quarter and full year ended December 31, 2016, along with business progress in the periods.

“Anika delivered another year of very strong growth, with 17% product revenue growth for the full year of 2016,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We also submitted an IND application to the FDA to initiate an additional Phase III clinical trial of CINGAL, and we received CE Mark approval for ORTHOVISC-T in the fourth quarter, paving the way for our next generation of growth drivers. We expect to commence the CINGAL Phase III trial and launch ORTHOVISC-T in Europe in the first half of 2017. Our strategic objectives in 2017 are focused on global commercial expansion, pipeline advancement, infrastructure enhancements and strategic M&A to drive sustained growth and create value for patients and shareholders.”

Fourth Quarter and Full Year Financial Results

Product revenue increased 11% for the fourth quarter of 2016, and 17% for the full year of 2016, as compared to the same periods in 2015.
Total revenue for the fourth quarter of 2016 was $28.7 million, compared to $30.9 million for the fourth quarter of 2015. The decline was due to the achievement of $5 million of contractual milestone revenue in the fourth quarter of 2015 for reaching a targeted MONOVISC U.S. end user sales threshold. Total revenue for the full year of 2016 grew 11% to $103.4 million, compared to $93.0 million for the full year of 2015.
Worldwide Orthobiologics revenue increased 13% year-over-year in the fourth quarter of 2016. For the full year of 2016, worldwide Orthobiologics revenue increased 22% and MONOVISC revenue grew 54%, which was the main overall revenue growth driver.
International Orthobiologics revenue increased 24% for the full year of 2016, due primarily to the global expansion of MONOVISC. Domestically, ORTHOVISC and MONOVISC continue to maintain a market leading position.
Total operating expenses for the fourth quarter of 2016 were $16.0 million, compared to $13.8 million for the fourth quarter of 2015, commensurate with the growth in product revenue, expanded commercial efforts and active pipeline development. Total operating expenses for the full year of 2016 were $52.8 million, compared to $44.9 million for the full year of 2015.
Net income for the fourth quarter of 2016 was $8.1 million, or $0.54 per diluted share, compared to $11.0 million, or $0.72 per diluted share, for the fourth quarter of 2015. Fourth quarter 2015 results reflected the favorable impact of the $5 million of licensing, milestone and contract revenue previously discussed. Net income for the full year of 2016 increased $1.8 million to $32.5 million, or $2.15 per diluted share, compared to $30.8 million, or $2.01 per diluted share, for the full year of 2015.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

Submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate an additional Phase III clinical trial of CINGAL.
Receiving CE Mark approval for a treatment, which will be marketed internationally as ORTHOVISC-T, indicated to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
Progressing with the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.

Full Year 2017 Corporate Outlook
Looking forward to 2017, the Company expects total revenue growth to be in the mid-teen percentage range for the full year of 2017. Licensing, milestone and contract revenue is expected to be $5 million for the year. The Company also anticipates continued headway on several key initiatives including:

Commencement of the Phase III clinical trial of CINGAL, to supplement the strong stable of existing pivotal data.
Launch of ORTHOVISC-T in Europe, and the initiation of a Phase III clinical trial for U.S. approval of the treatment.
International expansion of MONOVISC and CINGAL.
Continued progress toward full patient enrollment in the FastTRACK Phase III HYALOFAST study, with over 50% of the total patient population enrolled by the end of 2017.
Completion of the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.
Continued progress toward the development of a direct commercialization capability in the U.S.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, February 16^th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC^®, MONOVISC^®, and CINGAL^®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST^®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in the third and fourth sentences of the second paragraph, as well as all of the information in the section captioned “Full Year 2017 Corporate Outlook” of this press release, which are not statements of historical fact, are 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. These statements include, but are not limited to, those relating to the Company’s expectations regarding 2017 revenue growth, 2017 contractual milestone revenue, total 2017 operating expenses, product launches and territorial expansion for existing products, commencement of the CINGAL clinical trial, strategic objectives, including the Company’s focus on strategic M&A, progression of the HYALOFAST FastTRACK clinical trial enrollment, consolidation of manufacturing operations, and progress in the development of its direct commercialization capability. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.


Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)

	For the Three Months Ended December 31,				For the Year Ended December 31,
	2016		2015		2016		2015
Product revenue	$	28,296	$	25,607	$	102,932	$	87,696
Licensing, milestone and contract revenue		430		5,287		447		5,303
Total revenue		28,726		30,894		103,379		92,999

Operating expenses:
Cost of product revenue		7,539		6,290		24,027		21,053
Research & development		2,959		3,016		10,732		8,987
Selling, general & administrative		5,488		4,524		18,013		14,825
Total operating expenses		15,986		13,830		52,772		44,865
Income from operations		12,740		17,064		50,607		48,134
Interest income, net		49		39		263		120
Income before income taxes		12,789		17,103		50,870		48,254
Provision for income taxes		4,704		6,061		18,323		17,496
Net income	$	8,085	$	11,042	$	32,547	$	30,758

Basic net income per share:
Net income	$	0.56	$	0.74	$	2.22	$	2.06
Basic weighted average common shares outstanding		14,538		14,965		14,682		14,934
Diluted net income per share:
Net income	$	0.54	$	0.72	$	2.15	$	2.01
Diluted weighted average common shares outstanding		14,979		15,353		15,116		15,321


Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)

	December 31,			December 31,
ASSETS	2016			2015
Current assets:
Cash and cash equivalents	$	104,261		$	110,707
Investments		20,500			27,751
Accounts receivable, net of reserves of $194 and $167 at December 31, 2016 and December 31, 2015, respectively		27,598			21,652
Inventories		15,983			14,938
Prepaid expenses and other current assets		2,098			1,385
Total current assets		170,440			176,433
Property and equipment, at cost		79,079			64,648
Less: accumulated depreciation		(26,783	)		(24,540	)
Property and equipment, net		52,296			40,108
Long-term deposits and other		69			69
Intangible assets, net		10,227			11,656
Goodwill		7,214			7,482
Total Assets	$	240,246		$	235,748

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,303		$	8,302
Accrued expenses and other current liabilities		6,496			4,778
Current portion of long-term debt
Income taxes payable		–			4,198
Total current liabilities		8,799			17,278
Other long-term liabilities		2,078			781
Long-term deferred revenue		48			66
Deferred tax liability		6,548			6,775
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		–			–
Common stock, $.01 par value; 60,000 and 30,000 shares authorized, 14,627 and 15,037 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		146			150
Additional paid-in-capital		61,735			81,685
Accumulated other comprehensive loss		(7,317	)		(6,649	)
Retained earnings		168,209			135,662
Total stockholders’ equity		222,773			210,848
Total Liabilities and Stockholders’ Equity	$	240,246		$	235,748


Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data


Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)

	For the Three Months Ended December 31,										For the Year Ended December 31,
	2016			%		2015			%		2016			%		2015			%
Orthobiologics	$	24,376		86	%	$	21,530		84	%	$	89,695		87	%	$	73,247		84	%
Surgical		1,590		6	%		1,363		5	%		5,427		5	%		5,812		7	%
Dermal		1,114		4	%		1,134		5	%		2,759		3	%		2,266		2	%
Other		1,216		4	%		1,580		6	%		5,051		5	%		6,371		7	%
Product Revenue	$	28,296		100	%	$	25,607		100	%	$	102,932		100	%	$	87,696		100	%

Product Gross Profit	$	20,757				$	19,317				$	78,905				$	66,643
Product Gross Margin		73	%				75	%				77	%				76	%


Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)

	For the Three Months Ended December 31,										For the Year Ended December 31,
	2016			%		2015			%		2016			%		2015			%
Geographic Region:
United States	$	22,940		81	%	$	20,574		80	%	$	83,972		82	%	$	71,621		82	%
Europe		2,696		10	%		2,462		10	%		10,953		10	%		8,756		10	%
Other		2,660		9	%		2,571		10	%		8,007		8	%		7,319		8	%
Product Revenue	$	28,296		100	%	$	25,607		100	%	$	102,932		100	%	$	87,696		100	%

Contacts

Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., 781-457-9000
President and CEO
or
Sylvia Cheung, 781-457-9000
CFO

Invuity Reports 2016 Fourth Quarter, Annual Financial Results

Posted On February 16, 2017 By OrthoSpineNews In Financial /

SAN FRANCISCO, Feb. 14, 2017 (GLOBE NEWSWIRE) — Invuity, Inc. (NASDAQ:IVTY), a leading medical technology company focused on minimal access surgery, today reported financial results for the three months and year ended December 31, 2016.

Q4 2016 Highlights

Revenue grew 50% to $9.4 million compared to revenue of $6.2 million in the 2015 fourth quarter.
Gross margin expansion continued to 74.3% compared to 65.9% in the 2015 fourth quarter.
Approximately 745 hospitals purchased Invuity devices in the fourth quarter of 2016, up from 530 hospitals in the fourth quarter of 2015.
Approximately 240,000 procedures have been performed using Invuity devices.

“We finished 2016 on a strong note, delivering 50% year-over-year growth in the fourth quarter,” said President and CEO Philip Sawyer. “In 2017, we will continue to drive toward our goal of leadership in minimal access surgery through consistent execution of our commercial strategies coupled with the introduction of innovative, disruptive products.”

Financial Results

Revenue was $9.4 million in the fourth quarter of 2016, up 50% from revenue of $6.2 million in the fourth quarter of 2015 driven by an increase in active accounts and an increase in revenue per account. For the 2016 full year, revenue was $32.5 million, an increase of 54% over revenue of $21.0 million in 2015.

Gross margin for the fourth quarter and full-year 2016 was 74.3% and 72.8%, respectively, compared to 65.9% and 63.2% for the same periods in 2015. Gross margin expansion has been helped by the introduction of our non-conductive polymer based retractors, and by overhead efficiencies created as a result of increased sales volumes.

Total operating expenses for the fourth quarter and full-year 2016 were $16.0 million and $62.3 million, respectively, compared to $13.7 million and $48.5 million in the prior year periods. The increase in operating expenses is due to continued investment in our commercial platform, new product development costs and related increases in corporate infrastructure.

The net loss for the fourth quarter of 2016 was $9.6 million, or $0.56 loss per share, compared to a net loss of $10.1 million, or $0.76 loss per share, for the fourth quarter of 2015. The net loss for full-year 2016 was $40.6 million, or $2.73 loss per share, compared to $37.6 million, or $4.94 loss per share, for 2015.

The Company’s balance sheet as of December 31, 2016, included total cash, cash equivalents and short term investments of $39.0 million.

Business Outlook

Invuity is reiterating its revenue guidance for 2017 in the range of $42 million to $44 million.

Conference Call

Invuity’s management will discuss the Company’s financial results for the fourth quarter ended December 31, 2016, and provide a general business update during a conference call beginning at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time today, February 14, 2017. To join the live call, participants may dial 1-877-556-8638 (U.S.) or 1-615-247-0174 (International), Conference ID: 59656880. To listen to the live call via Invuity’s website, go to www.invuity.com, in the Events & Presentations section. A webcast replay of the call will be available following the conclusion of the call for a period of 90 days in the Events & Presentations section of the website.

About Invuity®

Invuity, Inc. is a leading medical technology company focused on developing and marketing advanced surgical devices to improve the ability of physicians to perform minimal access surgery through smaller and hidden incisions. The company’s patented Intelligent Photonics™ technology delivers enhanced visualization which facilitates surgical precision, efficiency and safety. In addition, the company utilizes comprehensive strategic marketing programs to create stronger institutional partnerships. Clinical applications include women’s health, encompassing breast cancer and breast reconstruction surgery, gynecology and thyroid surgery. Additional applications include procedures for electrophysiology, spine, orthopedic, cardiothoracic, and general surgery. Invuity is headquartered in San Francisco, CA. For more information, visit www.invuity.com.

Forward-Looking Statements

This announcement contains forward-looking statements that involve risks and uncertainties, including statements regarding financial projections for 2017, future product introductions, future sales and marketing initiatives, and market opportunities. Actual results could differ materially from those projected in the forward-looking statements as a result of certain risk factors, including, but not limited to: fluctuations in demand or failure to gain market acceptance for the Company’s devices; the Company’s ability to demonstrate to and gain approval from hospitals to use the Company’s devices; the highly competitive business environment for surgical medical devices; the Company’s ability to sell its devices at prices that support its current business strategies; difficulty forecasting future financial performance; protection of the Company’s intellectual property; and compliance with necessary regulatory clearances or approvals. The Company undertakes no obligation to update the forward-looking information in this release. More information about potential factors that could affect the Company’s business and financial results is included in its filings with the Securities and Exchange Commission, including, without limitation, under the captions: “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and “Risk Factors,” which are on file with the Securities and Exchange Commission.


INVUITY, INC.
Condensed Statements of Operations
(In thousands, except share and per share amounts)
(Unaudited)

	Three Months Ended December 31,						Year Ended December 31,
	2016			2015			2016			2015

Revenue	$	9,356		$	6,246		$	32,461		$	21,031
Cost of goods sold		2,409			2,127			8,824			7,733
Gross profit		6,947			4,119			23,637			13,298
Operating expenses:
Research and development		2,496			2,069			9,908			7,869
Selling, general and administrative		13,524			11,617			52,409			40,636
Total operating expenses		16,020			13,686			62,317			48,505
Loss from operations		(9,073	)		(9,567	)		(38,680	)		(35,207	)
Interest expense		(505	)		(505	)		(2,018	)		(1,881	)
Interest and other income (expense), net		28			17			89			(482	)
Net loss	$	(9,550	)	$	(10,055	)	$	(40,609	)	$	(37,570	)
Net loss per common share, basic and diluted	$	(0.56	)	$	(0.76	)	$	(2.73	)	$	(4.94	)
Weighted-average shares used to compute net loss per common share, basic and diluted		16,930,612			13,307,031			14,868,501			7,606,172

Condensed Balance Sheets
as of December 31, 2016 and December 31, 2015
(In thousands, except share and per share amounts)
(Unaudited)

	December 31,
	2016			2015
Assets
Current assets:
Cash and cash equivalents	$	28,300		$	46,296
Short-Term Investments		10,737			—
Restricted cash – Current		181			—
Accounts receivable, net		5,782			3,619
Inventory		5,052			5,182
Prepaid expenses and other current assets		1,088			923
Total current assets		51,140			56,020
Restricted cash		909			1,090
Property and equipment, net		8,286			9,195
Other non-current assets		—			—
Total assets	$	60,335		$	66,305
Liabilities, Stock and Stockholders’ Equity
Current liabilities:
Accounts payable	$	2,192		$	2,458
Accrued and other current liabilities		6,351			4,214
Short-term debt—related party		1,362			—
Total current liabilities		9,905			6,672
Deferred rent		2,721			2,810
Long-term debt—related party		13,261			14,480
Total liabilities		25,887			23,962
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value—10,000,000 shares authorized at December 31, 2016 and December 31, 2015, respectively; no shares issued and outstanding at December 31, 2016 and December 31, 2015		—			—
Common stock, $0.001 par value—200,000,000 shares authorized at December 31, 2016 and December 31, 2015 respectively; 16,950,940 and 13,392,358 shares issued and outstanding at December 31, 2016 and December 31, 2015, respectively		17			13
Additional paid-in capital		180,647			147,937
Accumulated deficit		(146,216	)		(105,607	)
Total stockholders’ equity		34,448			42,343
Total liabilities and stockholders’ equity	$	60,335		$	66,305

CONTACT:

Company Contact:
Jim Mackaness
Chief Financial Officer
Invuity, Inc.
415-655-2129

Investors:
Mark KlausnerWestwicke Partners
443-213-0501
irdept@invuity.com

Source: Invuity

Medovex Corporation Completes Phase II CE Mark Audit with Notified Body LNE/GMED

Posted On February 16, 2017 By OrthoSpineNews In Regulatory /

ATLANTA, GA–(Marketwired – Feb 15, 2017) – Medovex Corp. ( NASDAQ : MDVX ), a developer of medical technology products, today announced that the Company successfully completed its final CE Mark audit meeting. The review of the Company’s DenerveX™ System was conducted February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm. This audit is required to demonstrate compliance with the regulatory requirements to achieve CE Mark approval.

Patrick Kullmann, Medovex President and COO, stated, “We’re very pleased to have completed our certification audit of the DenerveX System February 7-9, 2017 at the Company’s Atlanta based offices. Our in-house development team, along with several representatives from our world-class suppliers and consultants, contributed extensively during this process due to their vast expertise in R&D, manufacturing, electro-surgery, regulatory, quality, and sterilization processes.”

Kullmann further stated, “Upon successfully completing this audit, the CE certificate would generally be expected to be issued paving the way to the future launch of the DenerveX System in the EU and other countries which accept the CE Mark.”

Previously on January 3, 2017, the Company announced it had successfully received certification of compliance for its DenerveX System from SGS S.A. a Swiss based multinational testing and certification firm. Compliance testing included electrical safety testing for US, Canada and the European Union.

Prior to that on November 3, 2016, the Company announced that it held a successful cadaver lab during NASS 2016. Medical advisory board members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD from Manchester, England, as well as Gabriel Davila, MD from Colombia, Latin America, highlighted the DenerveX System. Thirty spine surgeons from Europe and Latin America attended the lab, both experiencing and using the device.

Jarrett Gorlin, Medovex CEO, commented, “I’m very proud of our team and how they prepared for and handled this important event. Together, we have spent countless hours in anticipation of meeting with representatives of LNE/GMED. Although a date has not been provided for the anticipated receipt of the CE certificate or the launch of the product, we believe we remain well on our way to completing the final regulatory step in the process of achieving CE Marking.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options, and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system.
DenerveX system is not yet CE marked or FDA cleared and is not yet commercially available.

About Medovex
Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Nanovis announces a Successful Alpha Launch of the FortiCore® PLIF and the 2,000th FortiCore® Interbody Implantation.

Posted On February 16, 2017 By OrthoSpineNews In Spine /

Carmel and Columbia City, Ind. (February 16, 2017) – Nanovis, a life sciences company committed to developing implant systems that reduce fixation related complications and infections, today announced the successful alpha launch of its FortiCore^® PLIF featuring a deeply porous titanium scaffold interdigitated with a PEEK core, and implantation of the 2,000^th FortiCore^® implant.

“My patient’s short term response to the FortiCore^® PLIF has been positive. I implanted the interbody using a minimally invasive technique with no problems. The shape of the implant is favorable for multiple approach options. I’m encouraged by the deep porosity of the titanium scaffold in contact with the vertebral endplate and the pre-clinical data on this technology,” said Dr. Richard B. Rodgers, Goodman Campbell Brain and Spine, a participant in the alpha launch of the FortiCore^® PLIF.

With over 2,000 FortiCore^® implants now used in surgery, long term clinical experience with FortiCore’s^® deeply porous technologies has been positive. “In the 18 months since I started using FortiCore^® my patients have been doing well. Initially, I was interested in trying to improve my patient’s outcomes by using a deeply porous titanium scaffold. I’ve been pleased with the excellent radiologic on growth seen on X-ray at 8-12 weeks and the ease of imaging bone through the PEEK core,” said Dr. Gregory Hoffman, Orthopedics North East, an early adopter of the FortiCore^® technology.

FortiCore^® TLIF and PLIF implants were designed with deeply porous titanium scaffolds to contact the endplate and a radiolucent, favorable-modulus PEEK core injection molded into the bottom of the scaffold creating a durable construct. The FortiCore^® TLIF and PLIF systems are available with MIS or open instrumentation.

“Data comparing the osseointegration strength of the FortiCore^® scaffold, PEEK and allograft, to the strength of trabecular host bone published in Spine in October, 2016 was encouraging. One of Nanovis’ long term clinical and scientific goals is to reduce fixation related complications so we are delighted to hear positive reports from our customers about their experiences with FortiCore^®,” said Matt Hedrick, CEO, Nanovis.

Nanovis is actively recruiting for both employee Area Business Director positions and independent distributor partners and offers an independent distributor referral reward program. For information or a reprint of the Spine article mentioned, please contact Jeff Shepherd, Vice President of Sales, Nanovis at 1-877-907-NANO.

About Nanovis

Nanovis’ mission is to lead our select markets with science-enhanced, life-improving technologies. The Company’s patented and proprietary regenerative technology platforms provide differentiated surface advantages enabling the potential for existing medical devices to achieve new outcomes. Focused on aggressive, sustainable growth across multiple markets, Nanovis is commercializing science-driven platforms: the deeply porous scaffold currently available with the FortiCore^® line of interbody fusion devices; a developmental nanosurface technology; and developmental technology with anti-colonization and anti-microbial capabilities.

For more information about Nanovis, FortiCore^® or other proprietary Nanovis science-enhanced technologies, please visit www.nanovisinc.com or call 1-877-907-NANO.

Caption: Surface Structure: Nanovis’ FortiCore^® TLIF interbody fusion devices.

Media Contact:

Matt Hedrick

1-877-907-NANO (6266)

Matt.hedrick@nanovistechnology.com

Daniel J. Albright, MD Performs Mobi-C Two-Level Cervical Disc Replacement

Posted On February 16, 2017 By OrthoSpineNews In Spine /

RALEIGH, NC, February 15, 2017 — Daniel J. Albright, MD announced that he has performed two-level cervical disc replacement procedures utilizing a novel medical device recently approved by the FDA. The procedure was one of the first of its kind in the Raleigh North Carolina area.

The device, the first and only cervical disc replacement FDA approved for both one and two-level applications was the subject of a rigorous FDA Investigational Device Exemption (IDE) trial. In the study, the two-level cervical disc replacement procedure demonstrated an overall study success rate of 69.7% as compared to traditional cervical fusion results of 37.4%. At 24 months, those who received the two-level cervical disc replacement during the trial phase also returned to work on average three weeks earlier as compared to those patients who were treated with cervical fusion. The disc replacement patients also had lower rates of subsequent surgeries and reduced rates of ongoing degeneration at spinal segments adjacent to the surgery.

“I am very proud to be able to offer my patients this state of the art procedure which is supported by the highest level of medical evidence available for a medical device,” said Dr. Albright, of Raleigh Orthopedics. “And for the first time I am able to offer the significant number of my patients who suffer from two-level cervical disease a superior treatment option to traditional cervical spine fusion.”

About Daniel Albright, MD
Daniel J Albright, MD is a board certified orthopedic surgeon, who completed two fellowships in spine surgery and total hip and knee replacements. Dr. Albright joined Raleigh Orthopaedic Clinic in 1994.

Dr. Albright completed his undergraduate degree at Dartmouth College in Hanover, New Hampshire, and attended Louisiana State School of Medicine in New Orleans. He completed his residency in orthopedic surgery at Yale-New Haven Hospital. Following residency, Dr. Albright obtained additional training in Spine Surgery at St. Luke’s Medical in Cleveland, Ohio, and Knee & Hip Replacement and Revision Surgery at Massachusetts General Hospital.

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Month: February 2017

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