|MiMedx Issues Document Related to Misinterpretations of FDA's Proposed Draft Guidance; Genocea Presents Positive Findings from ATLASTM Immuno-Oncology Research Collaboration|
|By Josh Gee|
|Wednesday, 04 November 2015 20:35|
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 4, 2015.
UPDATED: MiMedx Group, Inc. (NASDAQ: MDXG), announced it will post a document to rectify misinterpretations arising from the publication of the Food and Drug Administration's ("FDA's") October 28, 2015 proposed Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products ("HCT/Ps"). The document entitled "Discussion of FDA's Draft Guidance on Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products" will be posted by mid-day today and will be accessible on the home page of the MiMedx website at www.mimedx.com.
Parker H. "Pete" Petit, Chairman and CEO, said, "As we have emphasized in our earlier communications on this topic, we assert that our products are in compliance with the homologous use positions taken by the FDA. We have further asserted that the proposed Draft Guidance position on homologous use is an instruction related to the marketing of HCT/Ps, as reflected by the labeling, advertising, or other indication of the manufacturer's objective intent for its products. The FDA has stated that its focus is on the promotion or labeling of HCT/Ps, rather than on their actual use. Although we have previously articulated these pertinent points, we decided to furnish a document that provides links to various FDA websites that confirm our position. We offer this document as a resource to assist with clearing up misconceptions, misunderstandings and misinformation on this subject and allow investors to verify the information themselves."
Bill Taylor, President and COO, added, "The myriad of FDA regulations, public statements and opinions from the Tissue Reference Group (TRG) can be confusing. Specifically, a statement on amniotic membrane appearing in this recent Draft Guidance apparently originated from the TRG 2014 annual report. This statement was a response from the TRG to an inquiry from another company requesting a determination based on their input to the FDA for the specific product they described. In fact, the request could have come from a competitor or a company that does not even market amniotic tissue. Regrettably, there is no requirement that submissions to the TRG be for a company's own products. This statement in question was not in reference to any MiMedx products. We realize that these types of statements meant for a specific product can be extremely confusing when not understood in the context in which they were made."
When publishing its product-specific recommendations, the TRG clearly states "Please keep in mind that updates to the TRG Annual Reports are stated in general terms in order to avoid revealing confidential information protected from disclosure. The TRG's recommendations are based on specific facts, which may not be provided in the updates. For these reasons, it may not be appropriate to generalize broadly from the updates."
"We market our products for homologous uses that have been recognized by the FDA. Amniotic membrane has been used in numerous wound covering and wound healing applications for over 100 years. These applications have been highly publicized over a long period of time and have been repeatedly referenced by the FDA. These references form the basis for MiMedx's position on marketing, labeling and intended use. In our document, we have also provided a compilation of the pertinent websites and sources to review the prior FDA communications," commented Petit.
The FDA issued this Draft Guidance in accordance with the time frame it had previously communicated. "We anticipated this Draft Guidance would be issued in the fall, and that the FDA would follow the proper protocol for industry and other involved parties to be advised of the scheduled hearing and provided adequate time in which to prepare and submit comments. The content of the Draft Guidance is as we expected, and we are satisfied that our practices are in full conformity," concluded Petit.
Genocea Biosciences, Inc. (NASDAQ: GNCA), announced findings that support the potential of ATLAS, the Company's proprietary rapid antigen identification screening system, to profile responses to immunotherapies for cancer. This analysis, in which ATLAS identified the specificity and characteristics of T cell responses in cancer patients, will be presented as a late-breaker at the Society for Immunotherapy of Cancer's (SITC) 30th Anniversary Annual Meeting & Associated Programs in National Harbor, Maryland. The poster, #342, entitled Immunoprofiling of T cell responses in melanoma patients undergoing CPI therapy, will be presented on Saturday, November 7, 2015 between 12:00 - 2:00 p.m. ET.
In this pilot study, funded by the Ludwig Trust, Genocea partnered with Darren Higgins, Ph.D., professor of microbiology and immunobiology at Harvard Medical School and F. Stephen Hodi, Jr., M.D., director of the Melanoma Center at Dana-Farber Cancer Institute, to conduct a retrospective analysis of 10 checkpoint inhibitor (CPI) treated patients' T cell responses to 23 known tumor-associated antigens. By analyzing the immune responses of both responders and non-responders to CPI therapy, ATLAS successfully identified the cancer antigens to which either (or both) CD4+ or CD8+ T cells became activated. Although this research was not powered to draw firm conclusions, the analysis of T cell responses in patients receiving CPI therapy revealed a pattern indicating a greater breadth of T cell activation for responders than non-responders. The study also revealed preliminary evidence that different characteristics of T cell responses emerge when comparing patients who respond and those who do not. Some T cell responses did not correspond with improved patient outcomes, and may be classified as "decoys," further validating the ability of ATLAS to distinguish clinically relevant targets of T cell responses.
"The breakthroughs we've seen in the immuno-oncology field to date have been profound, yet emerging treatment approaches do not yet include an understanding of who may respond to therapy and why," said Jessica Baker Flechtner, Ph.D., senior vice president of research at Genocea. "These findings provide strong proof of concept that ATLAS can take a panoramic view of a large, diverse population of cancer patients and reveal clinically relevant signatures of protective responses. We believe we are uniquely positioned to utilize our technology to enable smarter profiling – indicating what must be present to see a benefit from therapy – as well as smarter identification of T cell antigens to drive cancer vaccine development."
The collaboration with Dana-Farber is ongoing as Genocea continues to analyze more blood samples to characterize T cell response profiles that may be prognostic of CPI efficacy, and to identify T cell antigens that may be included in novel immunotherapies.
About ATLAS --- ATLAS is a first of its kind proprietary rapid antigen identification screening system that finds targets of protective T cell responses. The technology solves challenges to date associated with finding targets of T cell responses. ATLAS can examine T cell responses from large, diverse human populations, and comprehensively screen every potential antigen from a pathogen or target indication in a rapid, high-throughput manner, taking weeks versus years to find relevant antigens. Because targets identified by ATLAS are based on actual human immune responses to all potential antigens, with no guesswork or predictions, by the time these candidates reach clinical trials there may be a greater likelihood of success in clinical development. This approach provides the ability to identify smarter targets for use in developing vaccines and immunotherapies to treat infectious disease, cancer and autoimmunity.
About Genocea --- Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immunity. Using ATLAS, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea's pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company's website at www.genocea.com.
Aduro Biotech, Inc. (Nasdaq:ADRO) today announced that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, will present at the 24th Annual Credit Suisse Healthcare Conference on Wednesday, November 11, 2015, at 11:00 am Mountain Time.
To access the live webcast and subsequent archived recording of this and the company’s other presentations, please visit Aduro's website at www.aduro.com.
Almost Family, Inc. (Nasdaq:AFAM), a leading provider of home health nursing services, today announced that it has acquired the stock of Black Stone Operations, LLC (Black Stone) effective today. Black Stone, a provider of in-home personal care and skilled home health services has 2015 revenues approaching $50 million through service locations in the western half of Ohio and operates under the name "Home Care by Black Stone".
Third Quarter Earnings Announcement
In a separate release today Almost Family announced its financial results for the three and nine months ended October 2, 2015. The Company is reporting and commenting on its earnings in a separate simultaneously released statement to provide clarity to investors on both its earnings and the transaction separately.
ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced that two abstracts from the Company's immuno-oncology programs have been selected for presentation at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held November 5-9, 2015 in Boston, Massachusetts. The abstracts highlight clinical stage results in a pancreatic cancer trial with CCX872, the Company's second inhibitor of the chemokine receptor known as CCR2, and, separately, preclinical results in a model of triple negative breast cancer using combination therapy employing an antibody against the checkpoint inhibitor PD-L1 in conjunction with CCX9588, an inhibitor of the chemokine receptor known as CCR1.
"Tumors have devised ways to suppress anti-tumor immune responses in part by importing immune suppressor cells into the tumor microenvironment. One goal of our chemoattractant based immuno-oncology program is to develop treatments that specifically reduce the content of immune suppressive elements in the tumor mass, thus enabling the body's effector immune response to predominate," said Thomas J. Schall, Ph.D., President and Chief Executive Officer. "Towards this end, in our pancreatic cancer trial we are encouraged by observations to date of excellent coverage of the receptor CCR2, which guides suppressor cells to the tumor, by our drug CCX872, and we except to see greater than 90 percent receptor coverage continuously in the ongoing multi-dose portion of the study. Patient recruitment in the trial is ramping up, having reached 20 percent of the target enrollment, and we look forward to efficacy data from this trial in 2016. Also, our preclinical model work using a combination of checkpoint inhibitor antibody therapy in combination with an orally administered chemokine receptor inhibitor may pave the way for new treatment options in such important areas as triple negative breast cancer."
Codexis, Inc. (NASDAQ:CDXS), a leading protein engineering company, announces financial results for the three and nine months ended September 30, 2015, and provides an update on the company's business progress.
"We are reporting strong financial and operational performance with revenues exceeding $17 million and net income exceeding $5 million for the quarter," stated Codexis President and CEO John Nicols. "We earned combined payments totaling $11.5 million from GSK and Merck related to the successful achievement of milestones under non-exclusive licensing transactions for our CodeEvolver® protein engineering platform technology. Our ability to enter into and advance such licensing agreements is a critical component of our overall growth strategy. At present, both programs with these major pharmaceutical companies are progressing well and according to plan."
"We are delighted with our financial results and the successful advancements of our collaboration arrangements during the quarter and throughout the year. Accordingly, we are updating our 2015 financial guidance by increasing our gross margin outlook to a range of 80% to 85%, while affirming our expectation for revenues to be in the range of $41 million to $44 million," Mr. Nicols concluded.
CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal, miscarriage analysis and postnatal developmental disorders and pre-implantation genetic screening (PGS) services, today reported financial results for the three and nine months ended September 30, 2015, and provided a business update.
"We continue to perform and execute on key metrics in terms of driving testing volumes, adding new customers, securing reimbursement contracts, collecting cash, and entering and developing key markets. We delivered 23% revenue growth for the quarter as the business momentum established during the first half of the year continued," said Mark McDonough, CombiMatrix President and CEO. "Test volumes for our reproductive health services increased 37% and were driven by strong uptake in our PGS tests for women undergoing in vitro fertilization, which is a private-pay diagnostic service we launched in late 2014. Cash collections remained strong at 95% of revenue, and the number of billable customers increased to 234 for the quarter, up 34% from a year ago."
Among the Company's recent highlights, in August CombiMatrix announced that its CombiSNP™ Array for Prenatal Diagnosis was approved by the New York Department of Health (NYDOH), thereby opening a significant market opportunity. The Company secured five new contracts with major insurance carriers, adding more than 14 million covered lives and bringing the total number of covered lives under contract to approximately 170 million. Additionally, results of a CombiMatrix-sponsored study supporting the use of follow-up diagnostic testing to confirm non-invasive prenatal testing for both chromosomal aneuploidies and microdeletions were presented at a leading scientific conference.
"Our outlook is for continued revenue and volume growth driven by effective implementation of our commercial strategy. We are seeing particularly strong growth in reproductive health, notably in miscarriage analysis and pre-implantation genetic screening, and believe we are well positioned to benefit from continued opportunities as we focus on these services," added Mr. McDonough. "In addition, in the third quarter we completed training of the 10 sales representatives who were hired during the second quarter of this year and we expect increased productivity from the expanded salesforce in the coming months. We are also seeing accretive revenue contribution from the three new products that we launched over the past year, which is exciting and encouraging."
Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today provided a corporate update and reported financial results for the third quarter ending September 30, 2015.
"Our accomplishments since the second quarter have been transformational for Five Prime in many ways— highlighting our ability to discover and develop candidates and combinations to drive future immuno-oncology therapies, expanding our clinical programs and immuno-oncology pipeline, and strengthening our financial base going forward to augment and accelerate all of these activities," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "We recently announced an exciting license and collaboration agreement with Bristol-Myers Squibb (BMS) for our anti-CSF1R antibody, FPA008, which is a product of Five Prime's proprietary discovery platform and our identification of IL-34, one of the ligands that FPA008 blocks. As this agreement illustrates, we are well equipped to identify new approaches for modulating the tumor microenvironment, and we will leverage this ability as we look internally and externally at opportunities to grow our pipeline. It also demonstrates the quality of our clinical capabilities, and we look forward to continuing development of FPA008 in certain areas alongside BMS, and advancing our FPA144 and GITR programs."
Healthways, Inc. (NASDAQ: HWAY) will participate in The Stifel 2015 Healthcare Conference to be held November 17-18, 2015, in New York City. Donato Tramuto, Healthways president and chief executive officer, will participate in the conference at 10:15 a.m. EST (7:15 a.m. PST), Wednesday, November 18, 2015. The discussion will be available live online and also for replay on the "Investors" section of the Company's website, www.healthways.com. Please go to the site at least 15 minutes prior to the discussion to download and install any necessary audio software.
Immunomedics, Inc. (Nasdaq:IMMU) today reported financial results for the first quarter ended September 30, 2015. The Company also highlighted recent key developments and planned activities for its clinical pipeline.
First Quarter Fiscal 2016 Results
Total revenues for the first quarter of fiscal year 2016, which ended on September 30, 2015, were $0.7 million as compared to total revenues of $1.1 million for the same quarter last fiscal year. The decrease of $0.4 million in total revenues was primarily due to a $0.2 million reduction in research and development revenue from a decline in the number of government funded research grants and $0.1 million in reduced product sales due primarily to unfavorable currency rates on LeukoScan sales in Europe.
Total costs and expenses for the current quarter were $14.8 million as compared to $13.5 million for the same period in 2014, representing an increase of $1.3 million or 10%. This increase was driven primarily by $3.5 million higher research and development expenses for product development expenses related to the Phase 3 PANCRIT-1 registration study of yttrium-90-labeled clivatuzumab tetraxetan for the therapy of patients with advanced pancreatic cancer and the Phase 2 antibody-drug conjugates' clinical trials. The increase in cost and expenses this quarter was partially offset by the $2.1 million decrease in general and administrative expenses attributable primarily to reduced legal and professional fees, principally related to the arbitration proceedings with Takeda-Nycomed, which concluded during the 2015 fiscal year.
Interest expense this quarter related to the 4.75% Convertible Senior Notes was $1.4 million, including the amortization of $0.2 million debt issuance costs. There was no interest expense for the same quarter last fiscal year.
Net loss attributable to our stockholders this quarter was $15.4 million, or $0.16 per share, compared with a net loss attributable to our stockholders of $12.4 million, or $0.13 per share, for the same quarter in fiscal 2015. The $3.0 million increase in net loss this quarter was primarily due to $3.5 million increased clinical trial-related research and development costs and $1.4 million interest expense, partially offset by $2.1 million decreased legal and professional fees, as described above.
As of September 30, 2015, cash, cash equivalents, and marketable securities totaled $85.5 million.
Inogen, Inc. (NASDAQ:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today announced the Company plans to participate in the Stifel 2015 Healthcare Conference in New York, NY.
Inogen's CEO, Ray Huggenberger and CFO, Alison Bauerlein are scheduled to present on Wednesday, November 18, 2015 at 9:30am ET. Interested parties can access the live webcast and accompanying slides of this event from the Events section of the Investor Relations page on the Inogen website at www.inogen.com. A webcast replay will be available approximately one hour after the conclusion of the live presentation and will remain available for 90 days.
Inogen has used, and intends to continue to use, its Investor Relations website, http://investor.inogen.com/, as a means of disclosing material non-public information and for complying with its disclosure obligations under the Securities and Exchange Commission's Regulation FD. For more information, including a copy of our most recent Corporate Presentation, visit http://investor.inogen.com/.
The Joint Corp. (NASDAQ:JYNT), a national operator and franchisor of chiropractic clinics, today reported preliminary financial results for the quarter ended September 30, 2015.
Preliminary Third Quarter 2015 Results Highlights
LHC Group, Inc. (NASDAQ:LHCG), a national provider of home health, hospice, community-based and comprehensive post-acute healthcare services, today announced its financial results for the three months and nine months ended September 30, 2015.
Financial Results for the Third Quarter
"We remain intensely focused on our strategy to grow organically in existing markets and through acquisitions and hospital joint ventures in new markets and believe that we are well positioned to be a growth and consolidation leader in the years ahead of us. On the acquisition growth front, we completed the acquisition of Halcyon Hospice on October 1, which consists of 16 hospice locations across three states with annual revenue of approximately $41 million. This acquisition increases our hospice service line revenue by 56% and is consistent with our strategy of growing our three in-home service lines of home health, hospice and community-based services."
Lifestyle Medical Corporation (OTC:LMNK), is pleased to announce 4 new primary care physicians offices are now under management contract. Mr. Chris Smith, CEO of Lifestyle, stated "We are very excited about this opportunity for Lifestyle Medical Network to begin providing real solutions and new business models to practices throughout the country." Dr. Ronald Moomaw, D.O., added "Lifestyle is providing the tools necessary to help our practices function more efficiently, increase revenues, and most importantly allowing us to provide a higher standard of care to our patients."
Lombard Medical, Inc. (NASDAQ:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today reported financial results and provided an operational update for the third quarter and nine months ended September 30, 2015.
Q3 and Recent Operational Highlights
Nuo Therapeutics (OTCQX:NUOT), a pioneer in biodynamic therapies, announced today that it will report financial results for the third quarter of 2015 on Thursday, November 12, 2015, after the close of market.
Nuo Therapeutics will hold a conference call on Friday, November 13, 2015 at 8:00 a.m. ET to discuss the results and provide an update on recent strategic and operational initiatives. The dial-in numbers are 1-877-407-4018 for domestic callers and 1-201-689-8471 for international callers. The conference ID number for both is 13624377. A live webcast of the conference call will be available via the Events and Presentations page of the Company's investor relations website at http://www.nuot.com/investors.html.
After the live event, the webcast will remain available on the Company's website, www.nuot.com/investors.html, through December 13, 2015. In addition, a telephone replay of the call will be available until November 20, 2015. The replay dial-in numbers are 1-877-870-5176 for domestic callers and 1-858-384-5517 for international callers. Please use event passcode 13624377.
Revance Therapeutics, Inc. (NASDAQ:RVNC), a specialty biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today that the Company will release third quarter 2015 financial results on Monday, November 9, 2015 after the close of market. Revance will host a corresponding conference call and a live webcast at 1:30pm PT/4:30pm ET on the same day to discuss the results and provide a business update.
Individuals interested in listening to the conference call may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 48748347; or from the webcast link in the investor relations section of the Company's website at: www.revance.com.
A replay of the call will be available beginning November 9, 2015 at 4:30pm PT/7:30pm ET through midnight on November 10, 2015. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference Conference ID: 48748347. The webcast will be available in the investor relations section on the Company's website for 30 days following the completion of the call.
T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, announced that data on its investigational T2Bacteria Panel will be presented today at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.
"This is the first time study results demonstrate a rapid and sensitive bacterial species diagnosis direct from whole blood and without the need for blood culture," said Mike Pfaller, M.D., chief medical officer of T2 Biosystems. "The implications of these data are significant, enabling physicians to implement more timely targeted antibiotic therapy, potentially saving patient lives."
"The use of T2Candida and T2Bacteria, when combined with the practice of empirically administering broad spectrum antibiotics, may typically enable 95% of patients with sepsis to receive rapid and appropriate therapy," said John McDonough, chief executive officer of T2 Biosystems. "We are excited that the data in this study demonstrate the potential of T2Bacteria to enable the reduction in the current mortality rate of bacterial sepsis by 50%."
As previously announced, VBI Vaccines Inc. (NASDAQ:VBIV) and SciVac Therapeutics Inc. (TSX:VAC) (OTCQX:SVACF) will host a joint conference call for their respective shareholders at 3:00 P.M. Eastern Time on Thursday, November 5, 2015. The call will include a live webcast and be hosted by Jeff Baxter, President & CEO of VBI, and Dr. Curtis Lockshin, CEO of SciVac, who will together discuss the previously announced entry into a merger agreement whereby, subject to the satisfaction of certain conditions, a wholly owned subsidiary of SciVac will merge with and into VBI, with VBI surviving as a wholly owned subsidiary of SciVac. The conference call will provide shareholders of VBI and SciVac with an opportunity to ask appropriate questions regarding the proposed merger.
The webcast and conference call registration information is listed below:
WEBCAST AND CONFERENCE CALL INFORMATION:
WHEN: Thursday, November 5, 2015, 3:00 P.M. Eastern Time
TO REGISTER: Please visit: http://dpregister.com/10075803 to receive dial-in instructions for the conference call
WEBCAST: http://services.choruscall.com/links/vbi-scivac151105. Allow at least 10 minutes to access the site before the webcast begins.
VBI and SciVac will have posted prior to the conference call an investor presentation to accompany the conference call in the Investors sections of their respective websites.
For those shareholders unable to participate in the webcast or conference call, a transcript will be available on VBI's website at www.vbivaccines.com and SciVac's website at www.scivactherapeutics.com and will be filed with the U.S Securities and Exchange Commission by each of VBI and SciVac and available at www.sec.gov. Additionally, the webcast will be available for replay on VBI's and SciVac's respective websites for a period of 60 days.
Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for Wright Medical Group, Inc. for its third quarter ended September 30, 2015 and financial results for Tornier N.V. for its third quarter ended September 27, 2015. As previously announced, Wright and Tornier completed their merger on October 1, 2015, subsequent to the end of each company’s third quarter. Certain preliminary, unaudited non-GAAP pro forma financial results for the combined Wright Medical Group N.V. can be found on Wright’s website at ir.wright.com.
Wright Medical Group, Inc. Third Quarter 2015 Highlights
Net sales totaled $80.1 million during the third quarter ended September 30, 2015, representing a 12% increase as reported and 16% increase on a constant currency basis compared to the third quarter of 2014.
Robert Palmisano, president and chief executive officer, commented, “Third quarter results for our legacy Wright business continued to demonstrate the strong growth of our U.S. foot and ankle business and ongoing improvement in our international business. Specifically, our U.S. foot and ankle business grew 24% in the quarter, which was another quarter of significant growth driven by improved sales force execution, medical education and strong contribution from new products, including the ongoing launch of our INFINITY total ankle system, which drove 54% sales growth in U.S. total ankle replacement. In addition, our U.S. commercial launch activities for AUGMENT Bone Graft are off to a positive start following final FDA approval in September. We believe this product, coupled with continued strong growth in our core U.S. foot and ankle business, will continue to fuel positive momentum for the remainder of the year and beyond.”