Amedica Corporation Announces Pricing of $15,000,000 Public Offering of Units Consisting of Convertible Preferred Stock and Warrants

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 41st 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

Alphatec Reports First Quarter 2018 Financial Results and Recent Corporate Highlights

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.

Three Months Ended Change
March 31, 2018   December 31, 2017 $   %
(unaudited)
U.S. commercial revenue $   19,201 $   20,949 $   (1,748 ) (8 %)
U.S. gross profit   13,432   14,639   (1,207 ) (8 %)
U.S. gross margin 70.0 % 69.9 %
Operating Expenses
  Research and development $   1,786 $   1,437 $   349 24 %
  Sales and marketing   10,060   9,742   318 3 %
  General and administrative   6,442   7,243   (801 ) (11 %)
  Amortization of intangible assets   177   172   5 3 %
  Transaction-related expenses   1,542   –   1,542 NM
  Gain on settlement   (6,168 )   –   (6,168 ) NM
  Restructuring   398   308   90 29 %
  Total operating expenses $   14,237 $   18,902 $   (4,665 ) (25 %)
Operating loss $   (667 ) $   (3,608 ) $   2,941 82 %
Interest and other income (expense) $   (1,645 ) $   12,044 $  (13,689 ) (114 %)
Loss from continuing operations $   (1,854 ) $   (5,424 ) $   3,570 66 %
Non-GAAP Adjusted EBITDA $   (2,390 ) $   958 $   (3,348 ) (349 %)

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).

READ THE REST HERE

Globus Medical Announces Corporate Alliance Partnership with the Society of Lateral Access Surgery

AUDUBON, Pa., May 10, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, announced today it is sponsoring the Society of Lateral Access Surgery’s (SOLAS®) newly developed Partnership Program as that organization’s first corporate Alliance Partner.  SOLAS® is a non-profit organization that strives to shape the future of lateral access spine surgery through collaboration among members, exchange of ideas, and the promotion of new techniques that benefit patients, physicians and hospitals.  This sponsorship demonstrates Globus Medical’s commitment to supporting key educational and research initiatives important to advancing lateral access surgery.

“Globus Medical recognizes that SOLAS® is the largest surgeon organization focused primarily on advancing lateral access surgery through peer-to-peer interaction and clinical research”, said Andrew Iott, Senior Vice President Global Product Development. “As leaders in the musculoskeletal device industry, Globus Medical supports medical advancements in this area of spine surgery and recognizes its importance in improving patients’ lives.”

Globus Medical will attend the 11th Annual SOLAS® Meeting being held May 17-19 in San Diego as a Corporate Alliance Partner at the Fairmont Grand Del Mar. Globus representatives will showcase their comprehensive lateral implant and instrument solutions including seven different expandable lateral interbody fusion devices that allow for minimized insertion, continuous expansion, and an optimized fit for each patient.

“This is an excellent opportunity to engage with clinical thought leaders and highlight some of the latest advancements Globus has made with our lateral expandable devices”, said Mr. Iott. “The adjustable lordosis spacer options for the RISE-L® and ELSA® expandable spacer systems have received excellent feedback. We are excited to share how this technology can help surgeons maximize correction and address sagittal spinal imbalance from a lateral approach.”

Globus Medical invites meeting attendees to their exhibit space to experience its most recent product innovations and discuss future lateral advancements with the company’s product development experts.

To learn more about the Globus full line of lateral expandable spacers, visit www.GlobusMedical.com/LLIF

About Globus Medical, Inc.

Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at http://www.globusmedical.com.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to comply with changing laws and regulations that are applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. 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.

Contact:
Brian Kearns
Vice President, Business Development and Investor Relations
Phone: (610) 930-1800
Email:    investors@globusmedical.com
www.globusmedical.com

FDA seeks permanent injunctions against two stem cell clinics

SILVER SPRING, Md.May 9, 2018 /PRNewswire-USNewswire/ — The U.S. Food and Drug Administration, in two complaints filed today in federal court, is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements.

“Cell-based regenerative medicine holds significant medical opportunity, but we’ve also seen some bad actors leverage the scientific promise of this field to peddle unapproved treatments that put patients’ health at risk. In some instances, patients have suffered serious and permanent harm after receiving these unapproved products. In the two cases filed today, the clinics and their leadership have continued to disregard the law and more importantly, patient safety. We cannot allow unproven products that exploit the hope of patients and their loved ones,” said FDA Commissioner Scott Gottlieb, M.D. “We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health with inadequate manufacturing conditions or by purporting to have treatments that are being manufactured and used in ways that make them drugs under the existing law but have not been proven safe or effective for any use.”

A permanent injunction is being sought against US Stem Cell Clinic LLC of Sunrise, Florida, its Chief Scientific Officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing to patients stem cell products without FDA approval and while violating current good manufacturing practice requirements, including some that could impact the sterility of their products, putting patients at risk. The FDA is taking this action because US Stem Cell Clinic did not address the violations outlined in a warning letter to the clinic and failed to come into compliance with the law. The FDA is seeking an order of permanent injunction requiring US Stem Cell and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

The FDA is also seeking a permanent injunction to stop California Stem Cell Treatment Center Inc., with locations in Rancho Mirage and Beverly Hills, California; Cell Surgical Network Corporation of Rancho Mirage, California; and Elliot B. Lander, M.D. and Mark Berman, M.D., from marketing to patients stem cell products without FDA approval. Berman and Lander control the operations of approximately 100 for-profit affiliate clinics, including the California Stem Cell Treatment Center. The FDA is seeking an order of permanent injunction requiring California Stem Cell Treatment Center Inc. and Cell Surgical Network Corporation and the individual defendants to cease marketing their stem cell products until, among other things, they obtain necessary FDA approvals and correct their violations of current good manufacturing practice requirements.

US Stem Cell Clinic

The FDA issued a warning letter to US Stem Cell Clinic in August 2017 for marketing stem cell products without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could impact the sterility of their products. The warning letter also cited an FDA inspection of the clinic which found that it was processing adipose tissue (body fat) into stromal vascular fraction (a cellular product derived from body fat) and administering the product both intravenously or directly into the spinal cord of patients to treat a variety of serious diseases or conditions, including Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis. The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use.

During the inspection of US Stem Cell Clinic in April and May 2017, FDA investigators also documented evidence of significant deviations from current good manufacturing practices in the manufacture of at least 256 lots of stem cell products by the clinic. For example, the clinic was cited for its failure to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction against US Stem Cell Clinic was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Southern District of Florida.

California Stem Cell Treatment Center, Inc. and Cell Surgical Network Corporation

In August 2017, the FDA took action to prevent the use of a potentially dangerous and unproven treatment belonging to StemImmune Inc. in San Diego, California and administered to patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. On behalf of the FDA, the U.S. Marshals Service seized five vials of Vaccinia Virus Vaccine (Live) – a vaccine that is reserved only for people at high risk for smallpox, such as some members of the U.S. military. The seizure came after FDA inspections at StemImmune and the California Stem Cell Treatment Centers confirmed that the vaccine was used to create an unapproved stem cell product (a combination of excess amounts of vaccine and stromal vascular fraction – a cellular product derived from body fat). The product was then administered to cancer patients with potentially compromised immune systems and for whom the vaccine posed a potential for harm, including the possibility of inflammation and swelling of the heart and surrounding tissues. The unproven and potentially dangerous treatment was being injected intravenously and directly into patients’ tumors.

California Stem Cell Treatment Center products are also being used for the experimental treatment of patients who suffer from a variety of serious diseases or conditions, including cancer, arthritis, stroke, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD) and diabetes. The FDA has not approved any biological products manufactured by California Stem Cell Treatment Center for any use.

During inspections of California Stem Cell Treatment Center’s Beverly Hills and Rancho Mirage facilities in July 2017, FDA investigators documented, among other violations, evidence of significant deviations from current good manufacturing practice requirements. For example, the clinics were cited for failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of products purporting to be sterile, which puts patients at risk for infections.

The complaint for permanent injunction was filed by the U.S. Department of Justice on behalf of the FDA in the U.S. District Court for the Central District of California.

Regenerative medicine regulatory framework

These cases support the FDA’s comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies. The FDA issued four guidance documents in November 2017, two final and two draft, that build upon the FDA’s existing risk-based regulatory approach. Under this framework the FDA detailed its efficient, science-based process for helping to ensure the safety and effectiveness of these therapies, while supporting development in this area. One of the two draft guidance documents laid out a novel and efficient clinical development model by which promising cell-based products could pursue review and approval by the FDA. The suite of guidance documents also describes a risk-based framework for how the FDA intends to focus its enforcement actions against those products that raise reported safety concerns or potential significant safety concerns.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Lyndsay Meyer, 240-402-5345; lyndsay.meyer@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Related Links

http://www.fda.gov

UnitedHealthcare expands program for hip, knee and spine procedures

By  Star Tribune – May 9, 2018

Minnetonka-based UnitedHealthcare has expanded a program that is changing payment terms for certain hip, knee and spine surgeries in hopes of improving quality while lowering costs.

Launched as a pilot in 2015, the program is now saving employers about $18,000 per procedure, the insurer announced Wednesday, and has been expanded this year to nine new markets.

UnitedHealthcare, which is one of the nation’s largest health insurers, is part of a well-established trend across many private health insurers and government-run programs like Medicare to pay via “value-based care” contracts that include a degree of financial risk for doctors and hospitals when patient outcomes are poor.

“The program’s bundled payment method reimburses health care providers and facilities for a defined episode of care, such as knee or hip replacement, under a single fee or payment,” UnitedHealthcare said in a statement. “This is a shift away from the traditional fee-for-service structure in which a care provider is paid for each treatment, appointment or test, generating multiple claims within a single, broader episode of care.”

Paying as a package for all care connected to an orthopedic procedure is common among Minnesota’s nonprofit insurers, said Eileen Smith, spokeswoman for the Minnesota Council of Health Plans, a trade group for those carriers. Smith cited one example of a nonprofit health plan saving hip- and knee-replacement patients 20 to 25 percent compared to the old system.

At UnitedHealthcare, the Spine and Joint Solution program has saved money by giving health care providers incentives, the insurer said, to reduce return visits to the hospital as well as complications following surgery. It changes payment terms at certain facilities for hip- and knee-replacement surgeries, as well as fusion surgeries in the lumbar portion of the spine.

Complications following joint-replacement surgeries have been 17 percent lower at facilities in the program compared with other providers, the insurer said, and 3.4 percent lower for spine-surgery patients.

 

READ THE REST HERE

 

Photo: Jim Mone, Associated Press

 

ATTUNE Knee System Linked to Improvements in Patient Quality of Life and Reduced Length of Hospital Stay

WARSAW, Ind.May 10, 2018 /PRNewswire/ — DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced clinical findings outlining the potential benefits patients may experience when undergoing knee replacement with the ATTUNE Knee System.

First, a study1 presented at the 2nd World Arthroplasty Congress in Rome on Patient Reported Outcome Measures (PROMS) reported a statistically significant improvement in knee physical function at six months with the ATTUNE Knee compared to preoperative baseline, using the Knee injury and Osteoarthritis Outcome Score-Physical Function Short Form (KOOS-PS). The multicenter study of 200 cases from The Netherlands found that 80 percent of those ATTUNE Knee patients’ KOOS-PS improvements were realized by six months, with statistically significant improvements observed at intervals prior to six months. Also, pain and other PROMS were statistically significantly better at six weeks compared with pre-operative baseline.

“This multi-center outcomes study is further evidence of the positive performance of the ATTUNE Knee, and this study provides additional evidence on the rate of recovery – information that is useful when counseling patients before surgery,” said Geert Meermans, MD, Bravis Hospital, The Netherlands. “From my intraoperative and patient follow up experiences, the ATTUNE Knee appears to provide greater stability than other implants I have used, which may be a contributing factor to these positive results.”

Secondly, a report2 generated by DePuy Synthes summarized a series of studies across several countries with differing healthcare systems.  This report, entitled “The Impact of Implant Design on Hospital Length of Stay and Discharge Destination: Evidence Summary Report,” evaluated the connection between implant design and patient hospital length of stay (LOS), and encompassed some data that has been presented or accepted at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR).3-7 This retrospective review of five real-world evidence studies, conducted by DePuy Synthes in the US, UK, GermanyItaly and The Netherlands, was designed to evaluate whether patients treated with the ATTUNE Knee had a shorter hospital length of stay (LOS) versus a number of comparative implants. The report concluded that in each of these studies, the ATTUNE Knee patients were discharged from the hospital sooner than with the comparative implants used.3-7 

Reducing LOS is recognized as an effective way to lessen the financial burden of elective orthopaedics by reducing resource utilization, thereby lowering the overall cost of care.8 In addition, reducing LOS may also positively impact patient satisfaction. Emerging evidence detailed in this report2 suggests the ATTUNE Knee may facilitate earlier hospital discharge, with these studies observing a reduced length of stay between 0.19 and 4 days on average, depending on the comparative implants/countries compared against.3-7 While differences in healthcare systems limit the direct comparison of these observed statistically significant improvements in LOS, this report highlights the positive impact the ATTUNE Knee may deliver in various rehabilitation settings.

Commenting on the LOS findings to which his Center also contributed, Dr. Meermans concluded, “While it’s important to acknowledge that many factors can contribute to differences in length of stay, the data seems to suggest that implant design may be an important factor to consider in total knee arthroplasty procedures. This latest evidence gives me greater confidence that the device could help hospitals cost-effectively keep pace with the growing total knee arthroplasty demand.”

These findings come at a time when healthcare systems are facing unprecedented challenges due to demographic shifts and increases in demand due to the predicted global growth of knee replacement procedures.9 It is increasingly important for healthcare providers to demonstrate improved clinical, economic and patient reported outcomes to help minimize the total cost per procedure while maintaining and, where possible, improving quality of care.

Torbjorn Skold, Vice President, DePuy Synthes EMEA Joint Reconstruction added: “I’m delighted that this data demonstrated that study patients receiving the ATTUNE Knee experienced positive outcomes related to the rate of return of functional outcomes and reduced length of stay, allowing these patients to get back to a positive quality of life.”

Notes to Editors

About the Length of Stay (LOS) Report The Impact of Implant Design on Hospital Length of Stay and Discharge Destination: Evidence Summary Report”2

The purpose of this report was to summarize a series of 5 studies that were designed to evaluate whether patients treated with the ATTUNE Knee had a shorter LOS versus certain comparative implants. The studies were conducted in several countries with differing healthcare systems. All the studies in this report defined LOS as the primary endpoint. An additional study by Clement et al., (2017) conducted in Scotland also observed a statistically significant 1.2-day reduction (P<0.001) in LOS versus another leading knee system but is not included in this report as LOS was not the primary outcome.10

There are several important aspects of this report that limit the comparability of results among the studies and the generalizability to other institutions/countries. Due to factors within each country’s healthcare systems, baseline mean LOS will vary, which limits direct comparison of the means and differences between studies. Statistical analyses also differ by study as they controlled for different factors because of the feasibility of retrospective chart review/data collection at each site, which further limits the comparability of the results. This review however, was not intended to aggregate the data, it was to report each study in isolation and highlight the reductions in LOS seen in multiple healthcare settings following the adoption of the ATTUNE Knee.

Study summary

Study 1 examined insurance claims data across a range of US geographies and institution types (38 hospitals) including 1,178 US patients who received the ATTUNE Knee and 5,707 patients who received the Triathlon® Knee, with the patients receiving the ATTUNE Knee having a shorter average LOS (<0.19 day) compared to the Triathlon® Knee patients.  ATTUNE Knee patients were also 39% less likely to be discharged to a skilled nursing facility.3

Study 2 evaluated patients at a University Teaching Hospital in the UK, 238 of whom were implanted with an ATTUNE Knee, 332 with a SIGMA Knee and 149 with a Columbus® Knee.  Patients implanted with the ATTUNE Knee on average experienced a 0.8-day shorter LOS compared to SIGMA Knee patients and a 1-day reduction compared to patients treated with the Columbus® Knee. Both comparisons were statistically significant.4

Study 3 evaluated patients at a private German hospital, 85 of whom were implanted with the ATTUNE Knee compared to 85 implanted with the LCS Complete Knee System.  Patients in this study implanted with the ATTUNE Knee were discharged from hospital on average 2.1 days earlier than patients implanted with the LCS Complete Knee. This reduction in LOS was statistically significant.5

Study 4 evaluated two groups at a private Italian hospital: 100 patients implanted with the ATTUNE Knee and 100 patients who received a SIGMA Knee.  A statistically significant difference in LOS was observed: the patients implanted with an ATTUNE Knee were discharged from the hospital on average 4 days earlier than the patients implanted with a SIGMA Knee. 6

Study 5 evaluated two groups at a public hospital in The Netherlands: 100 patients implanted with the ATTUNE Knee and 100 patients implanted with the SIGMA Knee.  Both groups were treated with the same rehabilitation protocol.  Patients in this study who were implanted with the ATTUNE Knee were discharged from the hospital on average 0.67 days earlier than patients implanted with the SIGMA Knee. Similar to study 1,3 ATTUNE Knee patients were also less likely to be discharged to a rehabilitation center (referred to as a skilled nursing facility in the US).  For Study 5, the statistically significant improvements were achieved in a hospital environment with an established enhanced recovery program and a low baseline LOS.7

All the studies defined LOS as the primary endpoint. A copy of the full report can be found on ATTUNEevidence.com.

About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, interventional solutions and specialty surgery with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes

DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment.

The third-party trademarks used herein are the trademarks of their respective owners.

© DePuy Synthes 2018. All rights reserved.

References

  1. van Loon C, Meermans GBaas N, Vergroesen D, van Kampen P, Dwyer K, Lesko J, Huey V. Early Recovery Rate After A New Design Total Knee Arthroplasty (TKA): A Prospective, Multicenter Cohort of 200 Cases. Poster Accepted to World Arthroplasty Congress April 19-21, 2018Rome, Italy, Poster # P101.
  2. The Impact of Implant Design on Hospital Length of Stay and Discharge Destination Evidence Summary Report. 090088-180413. Available at ATTUNEevidence.com. Accessed April 2018.
  3. Etter K, Lerner J, Kalsekar I, de Moor C, Yoo A, Swank M. Comparative Analysis of Hospital Length of Stay and Discharge Status of Two Contemporary Primary Total Knee Systems. The Journal of Knee Surgery. 2017 Aug 25.
  4. Mantel J, Corso KA, Wei D, Holy CE, Muehlendyck C, Jayakumar P, Higgins M, Westbrook A. Economic Effectiveness Of The ATTUNE® Knee System-Analysis Of Real World Hospital Length Of Stay And Incidence Of Early Complications. Value in Health. 2017 Oct 1;20(9): A579.
  5. Brüggenjürgen B, Muehlendyck C, Gador L, Katzer A. Length of Hospitalisation After ATTUNE® Knee Joint Arthroplasty (TKA)-Results of A German Retrospective Database Analysis. Value in Health. 2017 Oct 1;20(9):A597.
  6. Pipino G, Paragò V, Corso KA, Wigham R, Holy CE, Do Rego B. Economic Outcomes Of The ATTUNE® Knee System: Analysis Of Real World Length Of Stay In An Italian Hospital. Value in Health. 2017 Oct 1;20(9):A595.
  7. Meermans G, Galvain T, Wigham R, Do Rego B, Schröer D. Comparative analysis investigating the impact of implant design on hospital length of stay and discharge destination in a Dutch hospital with an established enhanced recovery program. DSEM/JRC/0118/0984. Poster Accepted to ISPOR Annual Meeting May 19-23, 2018. Baltimore US. Presentation code PMD23.
  8. Briggs TWR. A national review of adult elective orthopaedic services in England: Getting it right first time. Available at: https://www.boa.ac.uk/wp-content/uploads/2015/03/GIRFT-National-Report-Mar15..pdf. Accessed April 2018.
  9. Patel A, Pavlou G, Mújica-Mota RE, Toms AD The epidemiology of revision total knee and hip arthroplasty in England and Wales: a comparative analysis with projections for the United States. A study using the National Joint Registry dataset. Bone & Joint J. 2015 Aug;97-B(8):1076-81.
  10. Clement N, Brenkel I, Walmsley P. IMPROVED EARLY FUNCTIONAL OUTCOME WITH THE ATTUNE TOTAL KNEE REPLACMENT: A PROPENSITY SCORE MATCHED TRIAL. 2017. Poster session presented at British Association for Surgery of the Knee, Southport, United Kingdom.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the ATTUNE Knee System*. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.

091374-180507

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

DePuy Synthes Announces Agreement with Prosidyan to Exclusively Promote FIBERGRAFT® Family of Products for Spine Fusion Surgery

RAYNHAM, Mass. – May 9, 2018 – DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Prosidyan to promote the FIBERGRAFT® Family of Products, a line of synthetic bone graft materials which are ultra-porous, designed for ease of use, and have been engineered for optimal resorption in clinical use during spine fusion surgery. By adding FIBERGRAFT to its offerings, DePuy Synthes will further enhance the company’s biomaterials portfolio for spine, which currently includes cellular allograft, demineralized bone matrix and first generation synthetic solutions. Surgeons will now have a broad range of handling options based on the needs of each patient and surgical case.

Approximately 400,000 patients in the U.S. undergo spinal fusion surgery annually to help reduce pain and nerve root inflammation.1 Surgeons will often use a biomaterial to facilitate bone growth and fusion. Each case is unique, and providing a broad portfolio of offerings allows surgeons the opportunity to select the right consistency.

“Our exclusive agreement with Prosidyan allows us to complete our biomaterials offering through a next generation synthetic solution and provide our customers with a variety of options based on handling preference and needs of their patients,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This offering allows us to provide a more complete solution for our customers.”

Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microsized fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. Prosidyan’s third and flagship product FIBERGRAFT BG Matrix, received FDA clearance in October of 2017 and comprised FIBERGRAFT BG Morsels combined with Prosidyan’s proprietary type I collagen based bioactive carrier.

To date, FIBERGRAFT products have been provided for more than 10,000 patients across the U.S.

DePuy Synthes is expected to begin promoting FIBERGRAFT in Q2 2018.


About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, and interventional solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.

About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit: www.depuysynthes.com.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional businesses within Johnson & Johnson’s Medical Devices segment.

Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding an agreement with Prosidyan to exclusively promote the FIBERGRAFT Family of Products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

The third party trademarks used herein are the trademarks of their respective owners.

©DePuy Synthes 2018. All rights reserved.

  1. Rajaee, Ss et al. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine. 2012 Jan 1;37(1):67-76.

Medtronic selects former analyst for senior finance post

By  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.

 

READ THE REST HERE

Permira funds to acquire Corin a leading orthopaedic company

London, 9 May 2018 – Global investment firm Permira and Corin Orthopaedics Holding Ltd (“Corin”), one of the fastest growing orthopaedic firms, today announced that a company backed by the Permira funds has signed a definitive agreement to acquire a majority stake in Corin from DeA Capital Alternative Funds SGR (controlled by DeA Capital Group), Hunt Capital, IP (Investimenti e Partecipazioni) and other investors, for an undisclosed sum. The investment provides substantial new funding to fuel the next stage of Corin’s development after 5 years of outstanding growth. Chief Executive Stefano Alfonsi and the management team will continue to lead Corin and will remain significant investors in the Company alongside the Permira funds.

Headquartered in Cirencester, UK, Corin is an international orthopaedic company with a direct presence in a majority of the world’s orthopaedic markets and a track record of strong double-digit growth. Corin aims to revolutionise orthopaedics by gaining, understanding and sharing insight at every stage of the arthroplasty experience. This unique combination of shared knowledge and clinically-proven implants delivers better outcomes and maximise healthcare value for patients, surgeons and healthcare providers.

Permira identified Corin as an attractive med-tech investment opportunity based on:

  • A very large orthopaedic implant market ($17.5bn) growing at 3% – 5% per annum as a result of increasing healthcare expenditures driven by long-term trends including a growing ageing population, more active elderly people and increasing obesity levels;
  • Challenger Original Equipment Manufacturers (OEMs) gaining market share in the orthopaedic industry through better product innovation, focus on customer service and enhanced software including positioning, patient monitoring and robotics;
  • A robust and scalable international platform with actionable organic and M&A growth opportunities;
  • A high-quality and experienced management team with a clear vision for the business.

Stefano Alfonsi, CEO of Corin, commented:

“We are delighted to partner with a leading investment firm like Permira to support us in achieving our ambitious growth plan. In the last five years we have laid the foundations for Corin to become a very competitive player in the orthopaedic industry. We are ready and excited for Corin’s future. I would like to thank our team for all their hard work which has been critical to the company’s success over the last 5 years and will be even more critical for the future.”

Silvia Oteri, Partner in Permira’s Healthcare Team, added:

“We are extremely excited to support Stefano Alfonsi and his outstanding management team in the next phase of Corin’s development. We have been following the orthopaedic industry for a long time and have been impressed by the rapid growth of challenger innovative companies like Corin. Since 2012, the Company has transformed from a basic orthopaedic manufacturer into a fast-growing international software-led orthopaedic-implant designer. We look forward to working with the team, and drawing on our significant healthcare and technology experience, to help the company capture further growth opportunities.”

Permira has an established track record of successfully partnering with market leading healthcare businesses, having deployed circa €1.5 billion of equity in the sector to date. The announced acquisition of Corin marks the Permira funds’ first investment in the orthopaedics’ market and 14th investment in the healthcare industry since inception.

Other recent healthcare investments have included: I-MED Radiology Network, the largest provider of diagnostic imaging services in Australia; LSNE a lyophilization contract manufacturing pharma specialist; Althea, a leading integrated provider of healthcare technology; Atrium Innovations, a global leader in the manufacturing, development and commercialisation of innovative, science-based health and nutrition products; PHARMAQ, one of the world’s leading manufacturers of vaccines and therapeutic products for the aquaculture industry and Creganna Medical, a global leader in the design and manufacture of “minimally invasive” surgical devices.

The transaction is expected to close in July 2018 following Antitrust approvals. The fund’s equity for the investment came from Permira’s dedicated global buyout fund Permira VI (€7.5bn, 2016). Following the completion of this investment, Permira VI will be circa 50% deployed.

Rothschild acted as financial advisers and Osborne Clarke as legal advisers to Corin. The Permira funds were advised by Vitale & Co, financial advisers, and Latham & Watkins LLP, legal advisers.

Media Contacts:

For Corin:

Elvio Gramignano, Global Strategic Marketing Director
+ 44 (0) 1285 884725
+ 44 (0) 7769 883 675

Rob Ashwell (Lucent Communication)
+44 (0) 7800 515 001

For Permira:

Noémie de Andia, Global Head of Communications

+44 207 632 1000
Noemie.deAndia@permira.com

James Olley (Montfort Communications)
+44 203 770 7909
jolley@montfort.london

About Corin
Since its inception, Corin has led the way in orthopaedic innovation — providing a faster, positive and more assured return to quality of life for people all over the world. Today, as a dynamic, growing, global business, Corin’s approach is revolutionising orthopaedics. We offer a unique combination of clinically-proven hip, knee, ankle and shoulder solutions and world-leading technologies that enable patients, surgeons and healthcare providers to connect more closely than ever. The deep insight we gain, understand and share at every stage of the connected orthopaedic experience leads to advanced, patient-specific solutions that exceed expectations, maximise value in healthcare and positively impact lives.

About Permira 

Permira is a global investment firm that finds and backs successful businesses with growth ambition. Founded in Europe in 1985, the firm advises funds with a total committed capital of approximately €32 billion. The Permira funds make long-term investments in companies with the ambition of transforming their performance and driving sustainable growth. Over more than three decades, the Permira funds have made over 200 private equity investments in five key sectors: Consumer, Financial Services, Healthcare, Industrials and Technology. Recent announced and completed investments from Permira VI include: Allegro, Alter Domus, Cisco’s Service Provider Video Software Solutions, Diversitech, Duff & Phelps, Cybersecurity and cloud software distributor Exclusive group, I-Med Radiology Network, LSNE, La Piadineria and Schustermann & Borenstein. For more information visit www.permira.com.

TransEnterix, Inc. Reports Operating and Financial Results for the First Quarter 2018

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.

TransEnterix, Inc.

Consolidated Statements of Operations and Comprehensive Loss

(in thousands except per share amounts)

(Unaudited)

Three Months Ended
March 31,
2018 2017
Revenue $ 4,767 $ 1,946
Cost of revenue 2,555 1,334

Gross profit

2,212 612

Operating Expenses (Income)

Research and development 5,265 6,855
Sales and marketing 5,970 3,723
General and administrative 2,676 3,049
Amortization of intangible assets

2,827

1,636

Change in fair value of contingent consideration

627

1,227

Gain from sale of SurgiBot assets, net

(11,996

)

Total Operating Expenses (Income)

5,369 16,490
Operating Loss (3,157 ) (15,878 )

Other Income (Expense)

Change in fair value of warrant liabilities

1,829

Interest expense, net (386 ) (334 )

Other expense

(58 ) (60 )

Total Other Income (Expense), net

1,385 (394 )
Loss before income taxes $ (1,772 ) $ (16,272 )
Income tax benefit 890 858
Net loss $ (882 ) $ (15,414 )

Other comprehensive income

Foreign currency translation gain

2,308

1,133

Comprehensive income (loss)

$ 1,426 $ (14,281 )
Net loss per share – basic and diluted

$

0.00

$

(0.13

)

Weighted average common shares outstanding – basic and diluted

199,900

121,660

 

 

READ THE REST HERE