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Anika Announces Appointment of Joseph Darling as President

Posted On July 27, 2017 By OrthoSpineNews In Biologics, Top Stories /  

July 27, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the appointment of Joseph Darling, an orthopedic and medical device veteran with broad commercial experience, to the role of President. For the past 15 years, the Company’s Chief Executive Officer (CEO), Dr. Charles H. Sherwood served as President and plans to transition the role to Mr. Darling, while continuing his tenure as CEO. Mr. Darling brings more than 20 years of executive management and leadership experience from publicly-traded, commercial-stage companies including Baxter Healthcare, Smith & Nephew, ConMed, and Wyeth-Ayerst.

“Anika is at the cusp of a transformation. We are ushering in the next decade of growth through the build-out of a direct commercialization capability, a steady march of global expansion, and a pipeline that includes multiple potential blockbuster products,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “With his established track record overseeing global sales and marketing efforts at leading medical device companies, Mr. Darling is uniquely suited to help drive continued growth and spearhead Anika’s direct commercialization initiative. The company’s leadership team and our Board are excited for Mr. Darling to bring his deep expertise to the table during this exciting period.”

Most recently, Mr. Darling held executive leadership positions with two small privately held orthopedic companies. Prior to these roles, Mr. Darling held senior level executive positions at ConMed Corporation, a global, publicly-held, diversified medical device company, as Global President of its wholly-owned subsidiary, Linvatec Corporation, and as Executive Vice President of Global Corporate Commercial Operations. At ConMed, Mr. Darling led five global business units with $760 million in annual revenues and refocused organizational efforts in sales, marketing, and R&D.

“Dr. Sherwood and his leadership team have built Anika into an innovative, high growth, profitable, and global orthopedic company with a diversified portfolio that includes differentiated, market-leading therapeutic products and an emerging orthopedic medicine pipeline with tremendous potential,” said Mr. Darling. “I’m excited to join Anika during, what I believe to be, a pivotal moment in its 25-year history. My extensive commercial operations background in the orthopedic sector will prove to be integral to executing the company’s long-term growth strategy.”

Before ConMed, Mr. Darling was Senior Vice President and General Manager for the sports medicine business at Smith & Nephew and played an important role in defining a global strategy that propelled the company to a leadership position in the sports medicine field. Mr. Darling launched his career at Abbott Laboratories and Wyeth-Ayerst Pharmaceuticals, where he held management positions in sales and marketing before joining Baxter Healthcare as a Vice President of marketing and health systems. Mr. Darling holds a Bachelor of Arts in Political Science from Syracuse University. Click HERE to view Mr. Darling’s full bio.

About Anika Therapeutics, Inc.

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

Forward-Looking Statements

The statements made in the first and second sentences of the second paragraph of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the Company’s direct commercial capability, global expansion efforts, and the strength of the Company’s product pipeline. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418
sonal@purecommunicationsinc.com

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Samumed Successfully Completed 52-Week Phase 2 Study for Treatment of Osteoarthritis of the Knee

Posted On July 27, 2017 By OrthoSpineNews In Biologics /  

July 27, 2017

SAN DIEGO–(BUSINESS WIRE)–Samumed, a leader in cartilage regeneration research, today announced the successful completion of a 52-week Phase II clinical trial of its potential treatment for osteoarthritis (“OA”) of the knee. SM04690 is a novel, small molecule inhibitor of the Wnt pathway, administered as an intra-articular injection. SM04690 appeared safe and well-tolerated at all dose levels studied. There were 29 serious adverse events reported, none of which were deemed related to SM04690, as assessed by the investigators. A detailed analysis of 52-week results of this Phase II study, including safety, pain and function scores, and disease modification, will be presented at future medical conferences.

“The completion of our Phase II clinical trial of SM04690 for the potential treatment of OA of the knee marks an important milestone for physicians, patients, and our development program,” said Dr. Yusuf Yazici, Samumed’s Chief Medical Officer. “While the current standard of care is focused on relieving signs and symptoms of the disease, SM04690 has the potential to be the first disease-modifying treatment approved for OA of the knee.”

Samumed presented 26-week interim data last month at the annual European League Against Rheumatism (EULAR) Congress in Madrid, Spain. SM04690, studied as a once annual injection, showed promising efficacy and safety at the six-month timepoint. The product appeared to potentially regrow cartilage, as demonstrated by increased medial joint space width on x-ray of the treated knee, and also appeared to improve both pain and function scores in patients compared to placebo. The presentations can be viewed at: http://bit.ly/2tZVN2lhttp://bit.ly/2sBTimi

SM04690 is in development as a potential disease modifying drug for knee OA (DMOAD) designed to increase chondrocyte production to generate new articular cartilage, reduce protease production to slow down cartilage degradation, and reduce inflammation in the joint. This Phase II trial was a randomized, double-blind, placebo-controlled study, to determine the safety and efficacy of SM04690. The study enrolled across 36 clinical sites in the US a total of 455 patients with moderate-to-severe OA of the knee. Subjects received a single injection of SM04690, with pain and function scores assessed by WOMAC and disease modification assessed by medial joint space width by x-ray. Study details can be reviewed at: http://bit.ly/2eOINuv

About Osteoarthritis (OA)

Arthritis is the most common cause of disability among adults, and OA is the most common type of arthritis, accounting for much of this burden. The overall number of US adults affected by OA in any joint has increased during recent decades, to 27 million in 2005, primarily due to an aging population and an ever-increasing prevalence of obesity. OA is characterized by pain, disability and joint deformity due to articular cartilage degradation and bone remodeling.

About Samumed, LLC

Based in San Diego, CA, Samumed (www.samumed.com) is a pharmaceutical platform company focused on advancing regenerative medicine and oncology applications through research and innovation. Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the team to develop small molecule drugs that potentially address numerous degenerative conditions as well as many forms of cancer.

Contacts

For Samumed
Chrissy Randall, 202-393-7337
crandall@brunswickgroup.com

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Back Pain Centers of America Announces Titan Spine as the Winner in the Awards of Excellence, “Technology Innovation” Category

Posted On July 27, 2017 By OrthoSpineNews In Spine, Top Stories /  

ATLANTA, GA (PRWEB) JULY 25, 2017

Back Pain Centers of America (BPC), which connects people searching for solutions to their neck and back pain with a reputable physician in their area, announces that Titan Spine’s nanoLOCK® Surface Technology is the winner of the 2017 Awards of Excellence for the Technology Innovation Award. This award is one of three categories of awards being presented in our 2017 series. The technology innovation award recognizes the top innovations advancing the field of orthopedic medicine.

The nanoLOCK® surface technology is a proprietary combination of textures at the macro, micro, and nano scales (MMN™) that has been shown to upregulate a significantly greater amount of bone growth factors necessary for fusion as compared to polyetheretherketone (PEEK), smooth titanium, and the company’s current titanium roughened surface. It is the next generation of the company’s current surface technology that has been implanted in patients since 2006.

“We are delighted to receive this award from Back Pain Centers of America,” said Andrew Shepherd, vice-president of marketing for Titan Spine. “Our nanoLOCK surface technology was developed with the goal of helping patients heal faster following back fusion surgery by interfacing with the patient’s cells at the nano level. We are pleased for the recognition it has generated.”

“We created this award category to recognize innovation and advances in medicine and technology,” said Brent Wheeler, president of Back Pain Centers of America. “We applaud Titan Spine for their innovation in taking spinal fusion procedures to the next level.”

More information about Titan Spine’s nanoLOCK® Surface Technology can be found at this link.

About Back Pain Centers of America
Back Pain Centers of America (BPC) has helped people find safe, reliable relief for chronic pain since 2009. The call centers match patients searching for relief for neck and back pain to reputable, board-certified healthcare practices in their geographic area. BPC has the largest network of minimally-invasive spine centers in America. This service is free to patients. For more information, please visit http://www.backpaincenters.com. Also follow BPC on LinkedIn, Facebook, or Twitter.

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Amplitude Surgical – FY 2016-17: H2 Sales of over €50m; Annual Sales of €93m, up +16%

Posted On July 27, 2017 By OrthoSpineNews In Financial /  

July 26, 2017

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its sales for its 2016-17 financial year.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “With new record half and full-year sales, 2016-17 perfectly illustrates Amplitude Surgical’s excellent dynamism since its creation in 1997, with 20 years of continuous strong organic growth. The result of the Group’s numerous assets, and notably its innovation and execution ability supported by efficient and motivated teams in every country in which we operate, the 16% increase in sales recorded over the financial year is perfectly in line with our implementation strategy, and bolsters our target of doubling sales in five years.”

Q4 2016-17 sales

 30/06/2017 30/06/2016 Δ actual

Δ constant
currency
€ thousands – IFRS
France 13,883 12,940 7.3% 7.3%
International 10,285 9,108 12.9% 10.2%
of which: Subsidiaries 7,400 6,085 21.6% 17.5%
of which: Distributors 2,885 3,023 -4.6% -4.6%
Total 24,168 22,048 9.6% 8.5%

FY 2016-17 sales

 30/06/2017 30/06/2016 Δ actual

Δ constant
currency
€ thousands – IFRS
France 58,145 52,318 11.1% 11.1%
International 35,192 28,416 23.8% 18.8%
of which: Subsidiaries 25,380 20,477 23.9% 16.6%
of which: Distributors 9,812 7,939 23.6% 23.6%
Total 93,337 80,734 15.6% 13.8%

Amplitude Surgical’s buoyant growth momentum continued over its 2016-17 financial year to June 30, 2017, with sales totaling €93.3 million, up +15.6% in actual terms and +13.8% at constant currency. Over the fourth quarter (from April to June), sales totaled €24.2 million, an increase of +9.6%, or +8.5% at constant currency.

On the French market, Amplitude Surgical continued to record solid growth, with annual sales of €58.1 million, up +11.1%, and fourth quarter sales of €13.9 million, up +7.3%. Thanks to the recruitment of numerous surgeons, the Group has again recorded significant market share gains.

The +23.8% growth in international sales to €35.2 million over the year can be attributed to both the buoyant growth achieved by the Group’s subsidiaries and the strong level of sales recorded through its distributors, and it also benefited from a positive currency effect. Indeed, at constant currency sales growth was 10.2% and 18.8% in the fourth quarter and in 2016-17 as a whole, respectively.

Over the year, the activity recorded by the Group’s subsidiaries, accounting for 72% of international sales, notably benefited from the solidity of the German and Benelux markets, while billings exceeded $3 million in the United States and sales from the Group’s new subsidiaries in South Africa and Japan totaled almost €1.3 million.

During the third year of marketing of Novastep products, innovative solutions for extremities (foot and ankle) surgery, sales totaled €6.1 million, up by over 60%, and now account for almost 7% of total Group sales. On the French market, which accounts for 40% of activity, sales grew by almost 45%, while on the extensive American market they virtually doubled to exceed $3 million.

Recent highlights

  • Strengthening of the sales teams in France

Amplitude Surgical has just completed the recruitment of a sizeable sales team in the Auvergne-Rhône-Alpes region. This 8-person team headed by Ralph Tempion has excellent knowledge of this region’s network of surgeons and hospitals.

  • Strengthening of the American sales teams

Amplitude Surgical is currently recruiting its American sales team with a view to shortly launching the commercialization of its hip and knee implants on the world’s largest market, estimated at around $10 billion.

With a cash position in excess of €40 million at the end of its 2016-17 financial year, Amplitude Surgical has the necessary means to finance its growth.

Next financial press release: 2016-17 annual results, Wednesday October 18, 2017, after market.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2017, Amplitude Surgical had a workforce of over 300 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia
CFO
+33 (0)4 75 41 87 41
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

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CTL Medical Secures FDA Clearance for Titanium Cage Device

Posted On July 26, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /  

DALLAS, TX – 07/25/2017 (PRESS RELEASE JET) — CTL Medical Corporation, a Dallas-based medical device manufacturing and service company, has secured FDA clearance to market its new MATISSE™ Titanium ACIF Cage implant with TiCro™ surface, used in the practice of spine fusion surgery.

The MATISSE™ Titanium ACIF Cage with CTL Medical’s proprietary TiCro™ surface technology offers 200 percent greater endplate contact surface area, as well as bone conforming geometry for increased mechanical locking at the cage and bone interface. The implant includes a tapered leading edge for easy insertion and a large graft area to further promote bony fusion. The device is available in a variety of sizes and configurations to accommodate variations in vertebral levels and patient anatomy.

“Countless engineering hours and R&D resources went in to developing CTL Medical’s patent pending TiCro™ surface technology, which was designed to expand our current portfolio, advance fusion technologies, and offer spine surgeons numerous surgical advantages,” stated Danny Chon, president & CEO of CTL Medical Corporation. “The Matisse™ system includes streamlined instrumentation and a variety of footprints, heights and lordotic profiles to accommodate variations in patient anatomy.”

MATISSE™ Titanium ACIF Cage with TiCro™ is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one-disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. MATISSE Anterior Cervical Interbody Fusion Cage system is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. MATISSE™ Titanium ACIF Cage with TiCro™ is to be used with supplemental fixation, such as CTL Medical’s VAN GOGH™ Anterior cervical plating system, which has been cleared for use in the cervical spine.

The use of cage devices in spinal surgery began with clinical trials in 1989, and since then, multiple implant improvements have debuted – leading to easier procedures, benefitting both spine surgeons and overall patient success and recovery times.

For more information on CTL Medical Corporation, visit www.ctlmed.com.

About CTL Medical Corporation
CTL Medical Corporation is a fully integrated, industry-leading, global medical device design, development and manufacturing company. CTL has assembled a world-class executive team, bringing together some of the industry’s most exceptional talent, positioning it to be a leader in medical device design and manufacturing. For more information, visit www.ctlmed.com.

Jeff Cheatham
TrizCom PR
O: 972-247-1369
C: 972-961-6171
jeffc@trizcom.com

Media Contacts:

Company Name: TrizCom PR
Full Name: Jeff Cheatham
Phone: (972) 247-1369
Email Address: SEND EMAIL
Website: www.trizcom.com

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MCRA Releases New White Paper Analyzing the Industry Impact of the Federal Budget Request on FDA

Posted On July 26, 2017 By OrthoSpineNews In Regulatory, Top Stories /  

WASHINGTON, July 26, 2017 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a leading advisory firm and Clinical Research Organization to the medical device industry, today announced that it has authored a new white paper, “The Potential FDA Impact of the 2018 Presidential Budget Request”. Following the release of the 2018 budget request, MCRA looked to analyze the potential impact of funding the Food and Drug Administration (FDA) Medical Device Review Program exclusively through user fees.

As the medical device market grows due to continued innovation and changing demographics, it is imperative for industry to be able to successfully commercialize their technologies and procedures within a reasonable and definable time frame. Since its latest iteration in 2012, the Medical Device User Fee Program has helped speed up decision times. With the new proposed budget request, uncertainty is a challenge companies will have to overcome. MCRA looks to define and clarify some of that uncertainty with this white paper.

The white paper is the result of the collaboration between Vice Presidents Glenn Stiegman and Tim Hunter, Senior Director Keith Tode, and Associate Jack Kiraly. Mr. Kiraly, a recent addition to the MCRA team, had this to say: “We are concerned by the proposed budget, however, even if passed, there will still be opportunities for industry to navigate regulatory pathways to approval.” MCRA has the experience of former FDA professionals, as well as an integrated team of regulatory, clinical, quality, reimbursement, and healthcare compliance specialists.

For more information on MCRA, please visit www.mcra.com. To read the white paper click here.

About MCRA

Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA’s integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

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Anika Reports Strong Second Quarter 2017 Financial Results

Posted On July 26, 2017 By OrthoSpineNews In Financial /  

July 26, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the second quarter ended June 30, 2017, along with business progress in the period.

“Anika delivered strong double-digit revenue and earnings growth in the second quarter of 2017, driven primarily by very robust demand for MONOVISC worldwide,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “MONOVISC U.S. end-user revenue increased 56% year-over-year in the second quarter, and exceeded our expectations for the quarter. We also made significant progress executing our global expansion strategy, as evidenced by international Orthobiologics revenue growth of 50% year-over-year for the quarter. Additionally, CINGAL continued to gain momentum in Canada and Europe, and we made considerable progress enrolling patients in our supplemental Phase III trial of CINGAL during the quarter.”

Second Quarter Financial Results

  • Total revenue for the second quarter of 2017 increased 26% year-over-year to $33.5 million, compared to $26.6 million for the second quarter of 2016. Total revenue for the second quarter of 2017 included $5.0 million in milestone revenue earned as a result of MONOVISC achieving $100 million in U.S. end-user sales within a consecutive 12-month period ending in June 2017.
  • Product revenue for the second quarter of 2017 increased 7% year-over-year to $28.3 million, compared to $26.6 million for the second quarter of 2016. Worldwide Orthobiologics revenue grew 5% year-over-year in the second quarter of 2017. The main driver of this product revenue growth was an increase in global MONOVISC revenue of 22% year-over-year in the second quarter of 2017, which was partially offset by a decline in ORTHOVISC revenue in the same period.
  • International Orthobiologics revenue increased 50% year-over-year for the second quarter of 2017, due primarily to the global expansion of MONOVISC, as well as growth of CINGAL in Canada and Europe. Domestically, ORTHOVISC and MONOVISC continue to maintain a combined market leading position.
  • Total operating expenses for the second quarter of 2017 were $15.7 million, compared to $13.1 million for the second quarter of 2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance the Company’s product pipeline, expanded operational efforts, and increased professional service fees.
  • Net income for the second quarter of 2017 increased 32% to $11.4 million, or $0.76 per diluted share, compared to $8.6 million, or $0.57 per diluted share, for the second quarter of 2016. The increase in net income was due primarily to an increase in total revenue.

Recent Business Highlights

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

  • Completing all site qualification activities and enrolling approximately 30 patients for the Company’s supplemental Phase III trial evaluating the efficacy and safety of CINGAL, its novel HA-corticosteroid combination viscosupplement for the treatment of symptoms associated with osteoarthritis (OA) of the knee. The Company expects to complete patient enrollment by the end of 2017.
  • Publishing results from the Company’s original Phase III trial of CINGAL in the peer-reviewed journal Cartilage. The data demonstrated that CINGAL provided improved immediate and short term pain relief after injection as compared to HA alone, and enhanced relief from OA-related pain, stiffness and function through 26 weeks as compared to saline.
  • Receiving regulatory approval for MONOVISC in India for the treatment of pain associated with osteoarthritis of all human synovial joints. The Company plans to expand into India, Australia, and New Zealand over the next six to nine months.
  • Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
  • Progressing the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters. The Company also opened its new European headquarters and surgical training center in Padova, Italy.

Conference Call Information

Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, July 27th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.

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

Forward-Looking Statements

The statements made in the last sentence of the first bullet point and the last sentence of third bullet point in the section captioned “Recent Business Highlights” of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to patient enrollment expectations with regard to the Company’s supplemental Cingal Phase III clinical trial and the Company’s international expansion expectations in the near future. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

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

For the Three Months Ended June 30,

For the Six Months Ended June 30,
2017 2016 2017 2016
Product revenue $ 28,340 $ 26,575 $ 51,721 $ 48,853
Licensing, milestone and contract revenue 5,122 6 5,127 11
Total revenue 33,462 26,581 56,848 48,864
Operating expenses:
Cost of product revenue 6,315 6,065 12,398 11,490
Research and development 4,449 2,792 8,679 4,951
Selling, general and administrative 4,972 4,255 10,039 8,245
Total operating expenses 15,736 13,112 31,116 24,686
Income from operations 17,726 13,469 25,732 24,178
Interest income, net 16 49 74 121
Income before income taxes 17,742 13,518 25,806 24,299
Provision for income taxes 6,373 4,903 8,944 8,789
Net income $ 11,369 $ 8,615 $ 16,862 $ 15,510
Basic net income per share:
Net income $ 0.78 $ 0.59 $ 1.16 $ 1.05
Basic weighted average common shares outstanding 14,588 14,679 14,582 14,778
Diluted net income per share:
Net income $ 0.76 $ 0.57 $ 1.12 $ 1.02
Diluted weighted average common shares outstanding 15,044 15,111 15,046 15,210
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
June 30, December 31,
ASSETS 2017 2016
Current assets:
Cash and cash equivalents $ 117,874 $ 104,261
Investments 25,000 20,500
Accounts receivable, net of reserves of $210 and $194 at June 30, 2017 and December 31, 2016, respectively 30,450 27,598
Inventories, net 17,584 15,983
Prepaid expenses and other current assets 1,973 2,098
Total current assets 192,881 170,440
Property and equipment, net 52,272 52,296
Long-term deposits and other 1,389 69
Intangible assets, net 10,626 10,227
Goodwill 7,836 7,214
Total assets $ 265,004 $ 240,246
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 5,465 $ 2,303
Accrued expenses and other current liabilities 7,976 6,496
Total current liabilities 13,441 8,799
Other long-term liabilities 422 2,126
Deferred tax liability 7,003 6,548
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively – –
Common stock, $.01 par value; 60,000 authorized, 14,658 and 14,627 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively 146 146
Additional paid-in-capital 65,171 61,735
Accumulated other comprehensive loss (5,736 ) (7,317 )
Retained earnings 184,557 168,209
Total stockholders’ equity 244,138 222,773
Total liabilities and stockholders’ equity $ 265,004 $ 240,246
Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)

For the Three Months Ended June 30,

For the Six Months Ended June 30,
Product Line: 2017 % 2016 % 2017 % 2016 %
Orthobiologics $ 24,468 86 % $ 23,304 88 % $ 44,695 86 % $ 42,891 88 %
Surgical 1,335 5 % 1,433 5 % 2,631 5 % 2,751 6 %
Dermal 453 2 % 582 2 % 878 2 % 963 2 %
Other 2,084 7 % 1,256 5 % 3,517 7 % 2,248 4 %
Product Revenue $ 28,340 100 % $ 26,575 100 % $ 51,721 100 % $ 48,853 100 %
Product Gross Profit $ 22,025 $ 20,510 $ 39,323 $ 37,363
Product Gross Margin 78 % 77 % 76 % 76 %
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
For the Three Months Ended June 30,

For the Six Months Ended June 30,
2017 % 2016 % 2017 % 2016 %
Geographic Region:
United States $ 22,331 79 % $ 21,895 82 % $ 41,261 80 % $ 39,906 82 %
Europe 4,060 14 % 2,977 11 % 6,889 13 % 5,542 11 %
Other 1,949 7 % 1,703 7 % 3,571 7 % 3,405 7 %
Product Revenue $ 28,340 100 % $ 26,575 100 % $ 51,721 100 % $ 48,853 100 %

Contacts

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

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Arlington Capital Partners Announces Acquisitions of Thortex and Millennium Surgical by Avalign Technologies

Posted On July 26, 2017 By OrthoSpineNews In Financial /  

July 25, 2017

WASHINGTON–(BUSINESS WIRE)–Avalign Technologies (“Avalign”), a portfolio company of Arlington Capital Partners (“Arlington Capital”), has completed the acquisitions of Thortex and Millennium Surgical (“Millennium”).

Thortex is a leading provider of proprietary porous coatings and metal injection molding as well precision manufacturing solutions to the medical device market. Thortex is one of the only companies in the world able to provide porous coating solutions for titanium and cobalt-chrome orthopedic implants. In addition, Thortex provides a full suite of manufacturing and engineering technologies including metal injection molding, CNC machining, finishing and assembly to medical device OEMs.

Millennium is a provider of specialty surgical instruments focused on delivering difficult-to-find instruments utilizing innovative, e-cataloging, web-based marketing tools, and technical sales support. Millennium offers more than 17,000 branded SKUs across a variety of clinical areas including neurosurgery, ophthalmics and orthopedics to a diverse array of hospital and ambulatory surgical center customers.

Matt Altman, a Managing Partner at Arlington Capital said, “The incorporation of Thortex and Millennium into the Avalign platform adds new and proprietary capabilities which enhance Avalign’s strategic position in the marketplace. The increased scale and breadth of services and technologies provided by these acquisitions will accrue to the benefit of Avalign’s customers and bolster Avalign’s already impressive growth.”

“Thortex and Millennium nicely complement and expand the manufacturing technologies and services that Avalign offers and provide us with the ability to continue gaining share with our customers,” said Forrest Whittaker, CEO of Avalign Technologies. “We are excited to welcome the Thortex and Millennium teams to the Avalign family, and thankful for Arlington’s support in consummating these highly strategic acquisitions.”

Malcolm Little, a Principal at Arlington Capital, added: “The proprietary technologies developed by both Thortex and Millennium represent truly unique offerings in the market. We are pleased to complete these acquisitions and continue to pursue additional opportunities to strategically scale our business.”

About Avalign Technologies

Avalign Technologies, Inc. (“Avalign”) is a leading provider of proprietary coatings and full-service precision manufacturer of implants, specialty instrumentation, cutting instruments, and delivery systems to the orthopedic medical device and specialty surgical markets. Avalign offers its OEM partners a broad portfolio of manufacturing technologies and coating solutions as well as extensive engineering design, development, and project management capabilities from concept to launch. Avalign has an established reputation for consistent and sophisticated quality systems, flexible capacity capabilities, innovative proprietary manufacturing technologies, unmatched product offering, and superior customer service.

About Arlington Capital Partners

Arlington Capital Partners is a Washington, D.C.-area private equity firm that has managed $2.2 billion of committed capital via four investment funds, including Arlington’s fourth and most recent $700 million fund. Arlington is focused on middle market investment opportunities in growth industries including: healthcare, aerospace/defense, government services and technology and business services and software. The firm’s professionals and network have a unique combination of operating and private equity experience that enables Arlington to be a value-added investor. Arlington invests in companies in partnership with high quality management teams that are motivated to establish and/or advance their company’s position as leading competitors in their field. www.arlingtoncap.com

Contacts

Arlington Capital Partners
Matt Altman or Malcolm Little
5425 Wisconsin Avenue, Suite 200
Chevy Chase, MD 20815
202-337-7500
202-337-7525 (fax)

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Paragon 28® announces launch of JAWS™ Nitinol Staple System to address fracture and osteotomy fixation of the foot

Posted On July 26, 2017 By OrthoSpineNews In Extremities /  

ENGLEWOOD, Colo., July 24, 2017 /PRNewswire/ — Since its inception, Paragon 28 has obsessed over every aspect of foot and ankle surgery. Committed to creating tailored solutions to improve surgical outcomes, Paragon 28 has launched innovative products and instrumentation to help streamline medical procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefiting both the surgeon and patient.

Paragon 28 designed the JAWSTM Nitinol Staple System for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments.

The JAWSTM Nitinol Staple System uses superelastic nitinol and a simple insertion method to gain rigid compression across an osteotomy site. Unlike many competitive implants, the JAWSTM Nitinol Staple System has a lightweight titanium inserter that allows the surgeon to fully seat the staple before it is released from the inserter. This allows for final placement of the staple before the staple compresses the osteotomy site.

Achieve compression upon insertion; no heating or electrical activation is required.

A low profile bridge (1.2 mm vs. competitive 1.5 mm or greater) helps minimize soft tissue irritation while the sharp-tooth geometry increases pull out resistance and helps resist migration during healing. Paragon 28 optimized the shape, angulation, and size of the staple legs to distribute compression evenly along the length of the legs. This helps eliminate plantar gapping and ensures consistent force across the osteotomy site.

All instrumentation for the JAWSTM Nitinol Staple System comes in a self-contained, disposable, sterile kit. The JAWS Nitinol Staple comes pre-loaded on the inserter to help facilitate a quick and straightforward surgery.

About Paragon 28, Inc. 
Paragon 28, Inc. was established in 2010 to address the unmet and under-served needs of the foot and ankle community. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

Product Pages: http://www.paragon28.com/products

CONTACT: Jim Edson, jedson@paragon28.com

 

SOURCE Paragon 28, Inc.

Related Links

http://www.paragon28.com

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Grossmont Orthopaedic Medical Group Performs First Meniscus Replacement in San Diego with NUsurface® Meniscus Implant

Posted On July 26, 2017 By OrthoSpineNews In Sports Medicine, Top Stories /  

July 25, 2017

SAN DIEGO–(BUSINESS WIRE)–Dr. Scott A. Hacker, an expert in arthroscopic surgery, total joint replacements, sports medicine and fracture care, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedure in San Diego has been performed. Dr. Hacker is the only physician in San Diego County – and Grossmont Orthopedic Medical Group is one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the ability of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

The recipient of the implant was Justin Marchand, 40-year-old Carlsbad resident and father of six. Four years ago, Marchand tore the meniscus in his left knee while practicing Brazilian Jiu-Jitsu drills, only to suffer a second tear in the same knee in 2014 while jogging. Although he underwent two partial meniscectomies to treat the tears, he continued to suffer from constant pain and swelling in his knee. As an avid surfer for over 25 years, Marchand went from surfing every day to once per week at best – with the expense of pain flare-ups after each session. His knee became extremely vulnerable to any type of sudden movement, and he was forced to limit all sports activities, including mountain biking, skiing and hiking.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“There aren’t many great options for patients like Justin, who experience persistent knee pain following meniscus surgery but are too young for knee replacement surgery,” Dr. Hacker said. “We hope the SUN study finds that the NUsurface implant alleviates pain in these patients, as well as helps them delay or avoid knee replacement surgery. Patients routinely ask me for something simple that could be put in the joint – this is that option they have been waiting for.”

Marchand received the NUsurface Meniscus Implant on July 25 in a short operation during which the implant was placed into his left knee joint through a small incision. He will now undergo a six-week rehabilitation program, after which time he can begin to resume work, leisure and sports activities.

“For the last four years, I had resigned myself to living with knee pain and limited mobility,” Marchand said. “As a father of six children, it has been particularly heartbreaking because I have not been able to go surfing with my kids or participate in the outdoor activities we love. I am hopeful that the NUsurface Implant will help me get back to my active lifestyle and allow me to go hiking with my family without persistent knee pain.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant is intended to mimic the function of the natural meniscus and redistribute loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel.

About Grossmont Orthopaedic Medical Group

Grossmont Orthopedic Medical Group is a premier Orthopedic center in San Diego caring for patients throughout southern California. The orthopedic surgeons of Grossmont Orthopaedic Medical Group, are consistently voted as top doctors in their field. As a group they have advanced training in arthroscopic surgery, total joint replacements, sports medicine and fracture care. The doctors are actively involved in many cutting edge research techniques allowing them to care for a wide range of orthopedic problems tailored to the individual and their needs. Their training, dedication, and experience are the prescription for successful orthopaedic treatment.

About Active Implants LLC

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Haarlem, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

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