WALTHAM, Mass., May 10, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operational results for the quarter ended March 31, 2018.

“The preparation for top-line data and the NeoCart Biologics License Application for the U.S. Food and Drug Administration remained a key focus for Histogenics in the first quarter of 2018, and we are on track to achieve these important milestones in the third quarter,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We are also actively supporting MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the planned confirmatory trial in Japan in the second half of 2018.  We also continue to work with our surgeon investigators on our commercialization plans in both the U.S. and Japanese markets, and are pursuing additional NeoCart licensing and partnership opportunities in other major international markets.  Our objective is to make NeoCart available to as many patients as possible with a goal of maximizing the clinical and commercial value of this innovative, restorative cell therapy that treats pain at the source,” continued Mr. Gridley.

First Quarter 2018 and Recent Highlights

• Release of NeoCart top-line Phase 3 Data and Submission of Biologics License Application on Track for Third Quarter 2018:  Histogenics expects to report top-line data from its 249-patient Phase 3 randomized, controlled clinical trial of NeoCart in the third quarter of 2018.  The trial is designed to show superiority of NeoCart at one year after treatment as compared to microfracture, the current standard of care.  The trial will follow patients for three years and is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration.
• Development of Additional NeoCart Biomechanical Data to Support Potential Commercialization:  As part of their Sponsored Research Agreement, Histogenics and Cornell University (Cornell) continue to build upon the robust body of evidence related to the biomechanical properties of NeoCart, with additional data that were presented at the Orthopaedic Research Society Annual Meeting in March 2018.  The body of data is intended to provide additional mechanism of action and physical competence information to regulatory agencies and clinicians regarding the potential performance advantages of NeoCart when compared to other treatment alternatives.  Furthermore, Histogenics and Cornell are working together in related areas including the novel testing and three-dimensional printing of cartilage tissue.  Histogenics believes this work may have significant utility in identifying and supporting additional future product opportunities including the automation of certain aspects of the NeoCart manufacturing process.
• Expansion and Enhancement of Board of Directors:  In April 2018, Susan Washer, President and Chief Executive Officer of Applied Genetic Technologies (AGTC) joined Histogenics’ Board of Directors.  Ms. Washer has served as CEO of AGTC, a company developing genetic therapies to treat patients with rare inherited conditions, since 2002.  She also serves on the boards of Biotechnology Innovation Organization and the Alliance for Regenerative Medicine.
• Receipt of MEDINET Licensing Agreement Proceeds and Completion of Financing:  Histogenics received a $10 million up-front payment from MEDINET Co., Ltd. (MEDINET) pursuant to the terms of the license agreement with MEDINET for the development and commercialization of NeoCart in Japan.  In addition, Histogenics successfully completed a registered direct offering of common stock in January 2018 that raised proceeds of $5.7 million, after deducting underwriter’s discounts and commissions, and expenses related to the offering.

Financial Results for the First Quarter of 2018

Loss from operations was $(6.1) million in the first quarter of 2018, compared to $(6.8) million in the first quarter of 2017.  The decrease in operating expenses was driven by a reduction in research and development expenses which was partially offset by an increase in general and administrative expenses.

Research and development expenses were $3.3 million in the first quarter of 2018, compared to $4.5 million in the first quarter of 2017.  The decrease was primarily due to a reduction in costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017.  General and administrative expenses were $2.8 million in the first quarter of 2018, compared to $2.3 million in the first quarter of 2017.  The increase was primarily due to increases in salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.

Net loss attributable to common stockholders was $(14.4) million in the first quarter of 2018, or $(0.52) per share, compared to $(5.8) million, or $(0.27) per share, in the first quarter of 2017.  The increase in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock into common stock and an increase in expense related to the fair value of the warrant liability which was partially offset by lower operating expenses.

As of March 31, 2018, Histogenics had cash, cash equivalents and marketable securities of $15.5 million, compared to $8.0 million at December 31, 2017.  Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, May 10, 2018 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 “8376199” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, 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, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; the scope, progress, timing, 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 following our technology transfer and manufacturing location transition; 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; 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, 2017, which is on file with 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 March 31, 2018, to be filed with the SEC in the second quarter 2018.  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.

Contact:

Investor Relations
Tel: +1 (781) 547-7909

SALT LAKE CITY, May 10, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ: AMDA) an innovative biomaterial company that develops and commercializes silicon nitride for biomedical applications, today announced the pricing of an underwritten public offering of units, consisting of convertible preferred stock and warrants, for gross proceeds of $15,000,000, which excludes underwriting discounts and commissions and offering expenses payable by Amedica.

The offering will be priced at a public offering price of $1,000 per unit. Each unit consists of one share of Series B Convertible Preferred Stock, with a stated value of $1,100, and warrants to purchase up to  758 shares of common stock (the “Warrants”). The Warrants are initially exercisable at an exercise price of $1.60 per share  and expire 5 years from the date of issuance.

The Series B Preferred Stock is convertible into shares of common  stock by dividing the stated value of $1,100 by:  (i) for the first 40 trading days following the closing of this offering, $1.45  (the “Conversion Price”), (ii) after 40 trading days but prior to the 81st trading day, the lesser of  (a) the Conversion Price and (b) 87.5% of the lowest volume weighted average price for our Common Stock as reported at the close of trading on the market reporting trade prices for the Common Stock during the five trading days prior to the 41^st trading day, and (iii) after 80 trading days, the lesser of  (a) the Conversion Price and (b) 87.5% of the lowest volume weighted average price for our Common Stock as reported at the close of trading on the market reporting trade prices for the Common Stock during the five trading days prior to the date of the notice of conversion. In the case of (ii)(b) and (iii)(b) above, the share price shall not be less than $0.48 (the “Floor Price”).  Each of the Conversion Price and Floor Price is subject to adjustment is certain circumstances.

Maxim Group LLC is acting as sole book-running manager in connection with the offering.

The securities are being offered pursuant to a written prospectus forming part of an effective registration statement on Form S-1 (File No. 333-223032) (“Form S-1”), which was declared effective by the United States Securities and Exchange Commission (“SEC”) on May 10, 2018.

This offering is expected to close on May 14, 2018, subject to satisfaction of customary closing conditions.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. A final prospectus relating to this offering will be filed by Amedica with the SEC. When available, copies of the final prospectus relating to this offering may also be obtained by contacting Maxim Group LLC, 405 Lexington Ave., New York, NY, 10174; Attn: Prospectus Department, or by Telephone: (212) 895-3745; or Email: syndicate@maximgrp.com.

About Amedica Corporation

Amedica is focused on the development and application of medical-grade silicon nitride ceramics. Amedica markets spinal fusion products and is developing a new generation of wear- and corrosion-resistant implant components for hip and knee arthroplasty. The Company manufactures its products in its ISO 13485 certified manufacturing facility. Amedica’s spine products are FDA-cleared, CE-marked, and are currently marketed in the U.S. and select markets in Europe and South America through its distributor network and its OEM partnerships.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties. For example, silicon nitride and our products may not have the impact we expect, the outcomes of our ongoing studies may not be positive, and the results of our studies may not come in the anticipated timeframes.   Other factors that could cause actual results to differ materially from those contemplated within this press release can also be found in Amedica’s Risk Factors disclosure in the Form S-1, its Annual Report on Form 10-K, filed with the SEC on March 29, 2018, and in Amedica’s other filings with the SEC.  Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contacts

Amedica IR 
801-839-3502
IR@amedica.com

CARLSBAD, Calif., May 10, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec,” “ATEC,” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today reported financial results for its first quarter ended March 31, 2018 and recent corporate highlights.

First Quarter 2018 Financial Highlights and 2018 Outlook

• Total net revenue of $21.3 million; U.S. commercial revenue of $19.2 million
• U.S. commercial gross margin of 70%
• Cash balance of $47.6 million at March 31, 2018
• Operating cash burn (excluding debt service) of $2.5 million
• Reiterated revenue guidance of approximately $95 million for full year 2018, with revenue growth expected to accelerate in the second half of the year

First Quarter Organizational, Commercial and Product Highlights

• Completed the acquisition of SafeOp Surgical, Inc. (“SafeOp”) to significantly differentiate the Company’s instrumented procedures and improve patient outcomes with advanced automated neuromonitoring technology
• Secured $50 million in equity financing to fund the cash purchase price of SafeOp and to strengthen the balance sheet for future growth initiatives
• Continued to drive momentum in the transition of the sales organization, expanding quality revenue from dedicated distribution partners and agents to nearly 50% of U.S. commercial revenue
• Increased number of surgeon visits to corporate headquarters for the fifth consecutive quarter, with revenue attributable to new surgeons increasing nearly 70% sequentially
• Appointed experienced spine executive Kelli Howell as Executive Vice President, Clinical Strategies

“We continue to build the foundation for long-term growth,” said Terry Rich, ATEC’s President and Chief Operating Officer.  “Reported financial results, even adjusting for seasonality, are not yet reflective of the operational and strategic progress made, but we believe the positive effects of our distribution transition and solid revenue contribution from new surgeons validate our strategy. Surgeon and distributor engagement is improving, the ATEC innovators are applying their experience to create an organic innovation machine, and excitement in the field is absolutely palpable.  We are on track to achieve our vision of becoming the most respected, fastest-growing U.S. spine company.”

Kelli Howell Appointed Executive Vice President, Clinical Strategies

Ms. Howell brings more than two decades of clinical research and education experience to the Company. As a member of ATEC’s senior leadership team, she will drive increased focus on clinical verification and validation, as well as develop plans for improved internal education programs, surgeon and sales education strategies, and market research initiatives. Ms. Howell joins the Company following an eighteen-year tenure at NuVasive, Inc., where she most recently served as Vice President of Research and Health Informatics following various research, education, and clinical resources roles.

“I am incredibly excited to welcome Kelli to the ATEC Family,” said Chairman and Chief Executive Officer, Pat Miles. “Many members of our team have worked with Kelli previously.  In fact, I collaborated with her for nearly 20 years.  We have witnessed her ability to drive market acceptance of innovative products through the use of clinically validated data and published, peer-reviewed research. I have great confidence that she will contribute immensely to our efforts as we work to distinguish ATEC as a leading provider of innovative solutions that improve outcomes.”

Comparison of Financial Results for the First Quarter 2018 to Fourth Quarter 2017

Following is a table comparing key first quarter 2018 results to fourth quarter 2017 results.  These are the comparisons management uses in its own evaluation of continuing operating performance given the re-focus of the Company’s strategy under the new leadership team.

U.S. commercial revenue for the first quarter of 2018 was $19.2 million, compared to $20.9 million in the fourth quarter of 2017.  Results were impacted by typical spine market seasonality, as well as the Company’s continued transition of its distribution channel to more dedicated, scalable partners. Revenue growth generated by expanding the dedicated sales channel, coupled with new surgeon adoption offset much of the revenue impact associated with transitioning or discontinuing non-strategic distributor relationships.

U.S. gross profit and gross margin for the first quarter of 2018 were $13.4 million and 70.0%, respectively, compared to $14.6 million and 69.9%, respectively, for the fourth quarter of 2017. U.S. gross margin has stabilized as the Company continues to reduce product costs and optimize its supply chain.

Total operating expenses for the first quarter of 2018 were $14.2 million compared to $18.9 million in the fourth quarter of 2017.  The decrease was driven primarily by a $6.2 million contract settlement gain recorded in the first quarter of 2018.  On a non-GAAP basis, which excludes restructuring charges, stock-based compensation, transaction-related expenses, and the gain on settlement, total operating expenses in the first quarter increased to $17.9 million, compared to $16.3 million in the fourth quarter of 2017.  The increase primarily reflects planned increased investments, including product development and strategic hiring.

Operating loss for the first quarter of 2018 was $0.7 million, compared to a loss of $3.6 million for the fourth quarter of 2017.

Non-GAAP Adjusted EBITDA for the first quarter of 2018 was $(2.4) million, compared to $1.0 million in the fourth quarter of 2017.  For more detailed information, please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures,” that follows.

Current and long-term debt includes $31.5 million in term debt and $8.4 million outstanding under the Company’s revolving credit facility at March 31, 2018. This compares to $32.4 million in term debt and $10.3 million outstanding under the Company’s revolving credit facility at December 31, 2017.

Cash and cash equivalents were $47.6 million at March 31, 2018, compared to $22.5 million reported at December 31, 2017.  During the first quarter of 2018, the Company raised net cash proceeds from a private placement and warrant financing of $46.4 million and paid $13.8 million for the acquisition of SafeOp. The Company also generated approximately $3.0 million in proceeds from common stock warrant exercises during April 2018, which is not reflected in the cash balance at March 31, 2018.

Comparison of Financial Results for the Three Months Ended March 31, 2018 and 2017

Revenue decreased on a year-over-year basis, as a result of the continued transition of its distribution channel to more dedicated, sustainable partners and the discontinuation of non-strategic distributor relationships. The year-over-year decrease in operating expenses is primarily the result of s $6.2 million contract settlement gain recorded in the first quarter of 2018; otherwise, operating expenses decreased slightly. For additional information, please reference the following financial statement tables and the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on or before May 11, 2018.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as sale of assets, settlement gains, impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company. For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call

Alphatec will hold a conference call today at 1:30 p.m. PT / 4:30 p.m. ET to discuss first quarter 2018 results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 2378857. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

Inducement Award Granted

As an inducement to accepting employment with the Company, and in accordance with applicable NASDAQ listing requirements, the Board of Directors has approved an award to Ms. Howell of 50,000 restricted stock units (RSUs) and 50,000 stock options (Options) at a strike price of $3.30 per share, the fair market value on March 12, 2018 (the grant date). The RSUs and Options will be granted following registration of the common stock underlying the RSUs and Options.  The RSUs will vest in equal annual installments on each of the first four anniversaries of date of employment, and the options will vest 25 percent on the first anniversary and in equal monthly installments of 1/36th of the balance of the Options, provided Ms. Howell remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs and Options will fully vest upon a change in control of Alphatec.  Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

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By Joe Carlson Star Tribune-May 8, 2018

Medtronic hired one of Wall Street’s best-known medical-technology stock analysts on Monday, with the goal of translating revenue growth into better stock performance. The stock price climbed nearly 5 percent on the news.

In a conference call with investors Monday morning, former JPMorgan Chase analyst Michael Weinstein said he has accepted a job as senior vice president of strategy at Medtronic, reporting to Chief Financial Officer Karen Parkhill. Weinstein is already deeply familiar with the complicated industry, having served as JPMorgan’s senior analyst covering med-tech companies including Medtronic, since 1995.

“We’re very excited to welcome Mike Weinstein. I couldn’t be more pleased that he decided to join our company,” said Medtronic CEO Omar Ishrak, who has often answered questions from Weinstein on earnings calls. “He will bring a new perspective that we know will enhance our growth strategies.”

Medtronic stock rose 4.6 percent Monday, closing at $84.82 on a day when the S&P 500 stock index was flat.

Analysts said the magnitude of Medtronic’s stock bump Monday could be a reflection of some market frustration with Medtronic.

Medtronic’s revenue growth has met Wall Street expectations since acquiring Covidien for $50 billion three years ago, but that has not translated into bottom-line growth that investors wanted to see.

During 2017, Medtronic’s stock price rose about 14 percent — trailing other large medical-supply peers, like Baxter (up 45 percent in 2017), BD (up 30 percent) and Abbott (up 46 percent). The S&P 500 index itself rose more than 18 percent last year.

“They’ve definitely underperformed over the past couple of years, relative to their peers,” said Raj Denhoy, an analyst who covers Medtronic for Jefferies Group.

Medtronic’s decision to have a conference call to announce Weinstein’s hiring Monday shows how seriously the company takes the idea of needing to improve shareholder value. “It seems to be a high priority for the company,” Denhoy said.

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May 08, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced its operating and financial results for the first quarter 2018.

Recent Highlights

• During the first quarter ended March 31, 2018, the Company sold two Senhance Systems
• In January of 2018, the Company filed a FDA 510(k) submission to expand the indications for use of the Senhance System, potentially doubling the Senhance System’s total addressable procedures
• Thus far in the second quarter ending June 30, 2018, the Company has sold three Senhance Systems, including one in the U.S.

“We continued to generate momentum in the first quarter of 2018, including delivering the second consecutive quarter with multiple Senhance system sales and progressing our U.S. indication expansion strategy,” said Todd M. Pope, President and CEO at TransEnterix. “Looking to the balance of 2018, we will continue to leverage the momentum we have generated to drive the global commercial adoption of Senhance.”

Commercial and Clinical Update

In the quarter ended March 31, 2018, the Company sold two Senhance Systems. Both of these sales have come from sales to end user hospitals by distributors in the Company’s EMEA (Europe, Middle East, and Africa) region.

In January of 2018, the Company filed a 510(k) submission with the FDA to expand the indications for use of the Senhance System to include laparoscopic inguinal hernia and gallbladder surgery. The Senhance System is currently cleared for use in the U.S. for laparoscopic colorectal and laparoscopic gynecologic surgery, accounting for approximately 1.5 million procedures in the U.S. annually. Upon clearance, we anticipate these additional indications would bring the Senhance System’s total addressable procedures in the U.S. to approximately 3 million.

Thus far in the quarter ending June 30, 2018, the Company has sold three Senhance Systems. One of the system sales was in the U.S., driven by the Company’s direct sales force, the remaining two system sales came from sales to end user hospitals by distributors in the Company’s EMEA region.

First Quarter Financial Highlights

For the three months ended March 31, 2018, the Company reported revenue of $4.8 million as compared to revenue of $1.9 million in the three months ended March 31, 2017. Revenue in the first quarter of 2018 included $3.5 million in system sales, $1.1 million in instruments and accessories, and $200 thousand in services.

For the three months ended March 31, 2018, total net operating income and expenses were $5.4 million, as compared to $16.5 million in the three months ended March 31, 2017.

For the three months ended March 31, 2018, net loss was $0.9 million, or $0.00 per share, as compared to a net loss of $15.4 million, or $0.13 per share, in the three months ended March 31, 2017.

For the three months ended March 31, 2018, adjusted net loss was $11.3 million, or $0.06 per share, as compared to an adjusted net loss of $12.6 million, or $0.11 per share in the three months ended March 31, 2017, after adjusting for the gain from the sale of SurgiBot assets and non-cash charges for amortization of intangible assets, change in fair value of contingent consideration, and change in fair value of warrant liabilities.

Conference Call

TransEnterix, Inc. will host a conference call on Tuesday, May 8, 2018 at 4:30 PM ET to discuss its first quarter 2018 operating and financial results. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers and reference conference ID 4854118 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Non-GAAP Measures

The adjusted net loss and adjusted net loss per share presented in this press release are non-GAAP measures. The adjustments relate to the gain on the sale of SurgiBot assets, amortization of intangible assets, change in fair value of contingent consideration and change in fair value of warrant liabilities. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles (“Non-GAAP Measures”). In the tables that follow under “Reconciliation of Non-GAAP Measures,” we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures. These items are adjusted because they are not operational or because these charges are non-cash or non-recurring and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP.

Forward-Looking Statements

This press release includes statements relating to the 2018 first quarter results and plans for 2018 and beyond. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether the expansion of the indications for use of the Senhance System will be approved, whether upon clearance the Senhance System’s total addressable procedures in the U.S. will more than double to approximately three million procedures, and whether we will be able to leverage the momentum we have worked to generate to drive the global commercial adoption of Senhance. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

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FARMINGDALE, N.Y., May 07, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today reported financial results for the third quarter of fiscal year 2018 ended March 31, 2018 as summarized below:

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, stated, “Misonix delivered solid financial results in the 2018 fiscal third quarter, including our second consecutive quarter of record revenue. The successful ongoing execution of our strategies to aggressively grow our leading ultrasonic medical device platform is providing Misonix with a solid foundation to continue expanding market share domestically as well as abroad. Importantly, our strong performance reflects our ability to achieve top line growth, while preserving healthy margins and maintaining a strong balance sheet and liquidity position, which allows us to continue making return-focused growth investments, including the development of our next generation of products.

“Our record third quarter revenue of $12.4 million includes $4 million of license revenue related to an agreement with a Chinese partner. In addition to the license revenue, we generated continued revenue growth across domestic and international markets, both on a quarterly and on a nine-month basis, as well as ongoing growth in both consumables and sales of our core products. Misonix’s strong revenue growth reflects growing market demand for our products, resulting in a 17% growth in product revenue for the quarter and a 24% increase year to date. We are also very pleased to see our consumables business continue its double-digit revenue growth trajectory, something the team has been laser focused on given the high margins and added predictability of this revenue stream. Excluding license revenue, consumables accounted for 70% of total sales for the quarter, including 88% of domestic sales.

“The strategic initiatives we have implemented through-out the company and the changes we have made are yielding positive results across our business and have positioned Misonix to pursue a range of near- and long-term profitable growth opportunities.

“Nexus, our next generation of products to be launched later this year, will present a compelling value proposition to both hospitals and physicians, while allowing Misonix to further penetrate operating rooms by expanding our addressable procedures. For the first nine months of fiscal 2018, over 45,000 surgical procedures have been performed with Misonix consumables, which positions us well to achieve our goal of 100,000 annual procedures world-wide within the next 3 years.

“Looking ahead, we are excited about the opportunities to enhance shareholder value by expanding our scale, growth and profitability. As we bring the next generation of products to market and complete our transformation to a direct commercialization platform, we remain confident in our ability to end fiscal 2018 with double-digit top-line growth and to continue that growth trend into fiscal 2019.”

Sales Performance Supplemental Data

Joe Dwyer, Chief Financial Officer, added, “Misonix generated record revenue and strong results across several key financial metrics in the 2018 fiscal third quarter, including net income, earnings per share, cash from operations and adjusted EBITDA, reflecting the ongoing success we are achieving in transforming our operations and cost structure to become more efficient, while implementing effective sales and marketing strategies focused on expanding our market footprint and creating added demand for our products.

“In the third quarter, we saw significant revenue contributions from our agreement with one of our Chinese partners, as we recognized $4 million in license revenue following the successful delivery of the SonaStar technology for future production in China. The license revenue was the main driver of the over 820 basis point gross margin improvement. Going forward, we expect gross margin to be in-line with recent results at around 70%.

“We also further strengthened our liquidity position, ending the fiscal third quarter with over $12.3 million in cash, while remaining debt free. We believe it is important to preserve our strong liquidity position while remaining as committed as ever to profitably growing the business through organic growth investments and select accretive acquisitions that will add complementary capabilities to our product portfolio and generate strong returns for our shareholders.

“With our focus on growth, disciplined expense management, efforts to drive operational efficiencies, emphasis on driving consumable sales and ongoing transition towards a direct sales force model, we are confident we are putting in place an operational structure that will appropriately position Misonix to achieve its potential and create significant value for shareholders.

“Given the strong performance in our fiscal third quarter and year-to-date results, we are increasing our total revenue guidance for the year ending June 30, 2018 to between $35 million and $36 million, which implies annual revenue growth of 28% to 32%.

Fiscal Third Quarter 2018 Conference Call
Misonix will host a conference call at 4:30 p.m. ET today, Monday, May 7, 2018.  Senior management will discuss the financial results and host a question and answer session.  The dial in number for the audio conference call is 800-263-0877 (domestic) or 323-794-2094 (international), conference ID 7937390. Participants may also listen to a live webcast of the call through the “Events and Presentations” section under “Investor Relations” on Misonix’s website at www.misonix.com.

A webcast replay will be available for 30 days following the live event at www.misonix.com.

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May 07, 2018

Gosselies, Belgium, 4 May 2018, 7am CEST – BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the bone cell therapy company addressing high unmet medical needs in orthopaedics and bone diseases, today provides a business update for the first quarter ended 31 March 2018.

Thomas Lienard, Chief Executive Officer of Bone Therapeutics, commented: “During the first quarter, we have seen continued progress of our ALLOB^® programme with the completion of recruitment into our Phase IIA lumbar spine fusion study. With the appointment of Jean Stéphenne as new Chairman and Claudia D’Augusta as senior Non-Executive Director, we have also significantly expanded the expertise in cell therapy, capital markets and corporate development in our leadership team. Supported by a successful convertible bond placement, we are excited to be advancing our products through the clinic closer to patients while preparing our products for commercial use and look forward to further value catalysts as we move through the year.“

Business highlights

• In February 2018, the Company announced the completion of patient recruitment into the Phase IIA lumbar spinal fusion study. This twelve-month, open-label clinical study aims to evaluate the safety and efficacy of the addition of ALLOB^® to the standard of care procedure, in which an interbody cage with bioceramic granules is implanted to promote fusion of the lumbar vertebrae.
• Promising interim results for the first 15 patients, reported in September 2017, showed radiological evidence of successful fusion in addition to substantial clinical improvement in function and a strong reduction in back and leg pain.
• Efficacy and safety data for the full set of 32 patients are expected in mid-2019, following a follow-up period of 12 months.

Corporate highlights

• In February 2018, Jean Stéphenne was appointed Chairman of the Board of Directors. Jean Stéphenne, a highly-experienced life sciences executive, has served in senior leadership roles at numerous biotechnology and pharmaceutical companies, including as Chairman of TiGenix and Chief Executive of GSK Biologicals (now GSK Vaccines).
• Post period, Claudia D’Augusta, Chief Financial Officer of TiGenix, joined the board as a Non-Executive Director, adding more than 20 years’ experience in corporate finance, capital markets and M&A in the biotechnology space.

Financial highlights

• In March, Bone Therapeutics secured a total amount of € 19.45 million in committed capital via a private placement of convertible bonds. Some of the investors decided to immediately exercise warrants resulting in immediate gross proceeds of € 6.58 million with 565,773 new shares to be created, increasing the total outstanding shares from 6,849,654 to 7,415,427 ordinary shares.
• As a result, the Company ended the first quarter of 2018 with a cash balance of € 10.42 million.
• The remaining warrants will be exercised over a maximum period of 19 months ending in October 2019, providing an additional proceed of € 12.87 million.

Outlook

• Bone Therapeutics plans to report final results from the ALLOB^® Phase I/IIA delayed-union study in mid-2018.
• A value inflection point is anticipated in the second half of 2018, as the Company expects to present the conclusions of the interim analysis after a one-year follow-up period of the first 44 patients in the Phase III study of PREOB^® in osteonecrosis of the hip.
• Additionally, the Company has started preparing for a multicentre, controlled Phase IIB study in delayed-union fractures with ALLOB^®.
• Cash burn for the full year of 2018 is expected to be in the range of € 15-16 million. Based on its current priorities, the Company expects to have sufficient cash to carry out its objectives until end Q3 2019.

About Bone Therapeutics

Bone Therapeutics is a leading cell therapy company addressing high unmet needs in orthopaedics and bone diseases. Based in Gosselies, Belgium, the Company has a broad, diversified portfolio of bone cell therapy products in clinical development across a number of disease areas targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics’ technology is based on a unique, proprietary approach to bone regeneration, which turns undifferentiated stem cells into “osteoblastic”, or bone-forming cells. These cells can be administered via a minimally invasive procedure, avoiding the need for invasive surgery.

The Company’s primary clinical focus is ALLOB^®, an allogeneic “off-the-shelf” cell therapy product derived from stem cells of healthy donors, which is in Phase II studies for the treatment of delayed-union fractures and spinal fusion. The Company also has an autologous bone cell therapy product, PREOB^®, obtained from patient’s own bone marrow and currently in Phase III development for osteonecrosis of the hip.

Bone Therapeutics’ cell therapy products are manufactured to the highest GMP standards and are protected by a rich IP estate covering nine patent families. Further information is available at: www.bonetherapeutics.com.

Contacts

Bone Therapeutics SA
Thomas Lienard, Chief Executive Officer
Jean-Luc Vandebroek, Chief Financial Officer
Tel: +32 (0) 71 12 10 00
investorrelations@bonetherapeutics.com

For Belgium and International Media Enquiries:
Consilium Strategic Communications
Amber Fennell, Jessica Hodgson, Hendrik Thys and Lindsey Neville
Tel: +44 (0) 20 3709 5701
bonetherapeutics@consilium-comms.com

For French Media and Investor Enquiries:
NewCap Investor Relations & Financial Communications
Pierre Laurent, Louis-Victor Delouvrier and Nicolas Merigeau
Tel: + 33 (0)1 44 71 94 94
bone@newcap.eu

For US Media and Investor Enquiries
Westwicke Partners
John Woolford
Tel: + 1 443 213 0506
john.woolford@westwicke.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors` current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person`s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.