Amedica Announces Agreement To Sell Spine Business To CTL Medical

SALT LAKE CITY, Sept. 06, 2018 (GLOBE NEWSWIRE) — Amedica Corporation (NASDAQ:AMDA) today announced that it has entered into an asset purchase agreement with CTL Medical, a Dallas, TX-based privately held medical device manufacturer that focuses on the spine implant and instrument market, whereby CTL Medical will acquire all of Amedica’s commercial spine business for total consideration of up to $10 million. The transaction is expected to close in the third quarter of 2018, and is subject to usual and customary due diligence and closing conditions.

The agreement will make CTL Medical the exclusive owner of Amedica’s portfolio of metal and silicon nitride spine products, with access to future silicon nitride spine technologies. As part of the transaction, CTL Medical will acquire Amedica’s entire existing inventory of spine products, including US and OUS regulatory clearances and intellectual property related to such. Amedica’s products, which are presently sold under the brand names of Taurus, Preference, and Valeo will be transferred to CTL Medical, while manufacturing, R&D, and all intellectual property related to the core biomaterial technology of silicon nitride will remain with Amedica in Salt Lake City. Amedica will serve as CTL’s exclusive OEM provider of silicon nitride products.

Following the purchase, CTL Medical will change its name to CTL Amedica. Amedica will re-position under a new name that is reflective of the breadth of its technology and potential applications.

“The transaction makes strategic sense, by monetizing our commercial spine sales organization and allowing Amedica to focus on its core biomaterials and OEM business,” said Dr. Sonny Bal, Chairman of the Board of Directors of Amedica. “Combining the mutually complementary products, customers, and sales regions of the two companies will offer significant accretive value to our shareholders. The addition of a highly-differentiated silicon nitride and metal product line to CTL Medical’s complete offering of spine surgery implants and instruments will benefit both companies, as well as our surgeon customers. Amedica’s products and scientific data have established that silicon nitride resists bacteria, promotes bone healing, and has superior clinical outcomes. CTL Medical is best positioned to profitably leverage these advantages in the retail spine market.”

“Going forward, Amedica will actively support spine sales by CTL Medical, specifically through surgeon education, peer-forums, publications, and research related to silicon nitride. Divesting the sales organization will drive down costs, while allowing Amedica to focus on additional OEM revenue opportunities outside of spine, such as in the dental and arthroplasty markets. As additional downstream opportunities with CTL Medical become apparent in the future, they will be explored as well.” added Dr. Bal.

“CTL Medical is a fast-growing, profitable company, with a complete line of FDA 510k cleared, market-tested spine products, in-house manufacturing facilities and an experienced sales team. Adding the credibility of Amedica’s products and technology, to which over 70 peer-reviewed publications already attest, to our product portfolio will generate new opportunities both in the U.S. and overseas” said Daniel Chon, President and CEO of CTL Medical. “Our team was deeply impressed at how far Amedica has taken its technology, in terms of breadth of application, as well as the quality, discipline, and depth of Amedica’s scientific inquiry. Onward, our goal is to apply the attributes of silicon nitride across our entire product line. CTL Medical will be the only company worldwide to offer such technology, further strengthening our position as an industry leader” added Mr. Chon.

Amedica is an innovative biomaterials and OEM company that develops and commercializes silicon nitride for various biomedical applications including orthopedic, dental and arthroplasty. CTL Medical is a forward thinking medical device design, development and manufacturing company that produces a full line of cervical, thoracic, and lumbar products (hence “CTL”) at its manufacturing headquarters in Dallas, Texas.

Maxim Group LLC is serving as Amedica’s strategic advisor. Amedica intends to host a conference call on September 13, 2018 to discuss the agreement with CTL Medical, and to provide a business update. Details related to this call will be provided at a later date.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). Such forward-looking statements include but are not limited to statements about the consummation of the transaction, the benefits of the transaction, including future accretive value to CTL and Amedica’s future financial results, operating plans, objectives, expectations and intentions, and other statements that are not historical facts. These forward-looking statements are subject to risks and uncertainties that may cause actual results or events to differ materially from those projected, including but not limited to the risks that the transaction does not close when expected or at all because required regulatory, shareholder or other approvals and other conditions to closing are not received or satisfied on a timely basis or at all; the risk that the benefits from the transaction may not be fully realized or may take longer to realize than expected, including as a result of changes in general economic and market conditions, interest and exchange rates, monetary policy, laws and regulations and their enforcement, and the degree of competition in the geographic and business areas in which Amedica and CTL operate; the ability of CTL to promptly and effectively integrate Amedica’s commercial spine business; the reaction to the transaction of the companies’ customers, employees, and counterparties; and the diversion of management time on transaction-related issues. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. Amedica undertakes no obligation to publicly revise or update the forward-looking statements to reflect events or circumstances that arise after the date of this report.

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

Source: Amedica Corporation

This article appears in: News Headlines

Referenced Stocks: AMDA

Innovasis Announces Successful Launch of TxHA™

SALT LAKE CITY, September 6, 2018 – Innovasis is pleased to announce the commercial launch of TxHA, ™ a TLIF interbody fusion device offering PEEK Optima HA Enhanced polymer.

Designed for use in spinal fusion procedures, the TxHA interbody device contains osteoconductive hydroxyapatite (HA) fully integrated into the polymer and exposed on all surfaces of the implant. This product follows the successful launch of Px HA (PLIF interbody) and Ax (Stand-alone ALIF) last year.

The first surgery was completed by Dr. Lavelle in Syracuse, NY. “The case went extremely well! The interbody and instrumentation is well designed and allowed for an easy and straightforward implantation. With this material technology you can expect better fusion rates.” said Dr. Lavelle. “HA PEEK is the future of PEEK interbodies.”

The Innovasis TxHA™ Transforaminal Lumbar IBF System is an intervertebral fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). The implant is used to facilitate fusion in the lumbar spine and placed via a transforaminal approach. The TxHA implant also features a tapered leading edge to ease insertion, a convex profile to match anatomy, tantalum markers for improved visualization, and pyramidal teeth for migration resistance.

About Innovasis

Innovasis is a groundbreaking company engaged in the research, development, manufacturing, and marketing of spinal implant devices and related products. Innovasis offers a spinal product line with implants and instruments that address the major pathologies and focus areas of traditional spinal surgery.

Anika Appoints Dr. Cheryl Blanchard to Its Board of Directors

September 05, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK) (“Anika” or the “Company”), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced that Cheryl R. Blanchard, Ph.D., President and Chief Executive Officer of Keratin Biosciences, Inc., has been appointed as a new independent member of the Company’s Board of Directors with a term continuing through the Company’s 2019 Annual Meeting of Stockholders. With Dr. Blanchard’s appointment, the Board of Directors has been expanded to seven directors.

“With more than 30 years of leadership and board experience in medical devices and biotechnology, Cheryl is an outstanding addition to Anika’s Board,” said Joseph L. Bower, Chairman of the Board. “We are committed to strong corporate governance. We continue to actively evaluate the composition of our Board to ensure we have the right mix of expertise, independence, and experience to best position Anika for the future.”

“Cheryl has an impressive track record of delivering strong business results, and I am pleased she is joining Anika’s Board,” said Joseph G. Darling, President and CEO of Anika. “As we undergo a shift from palliative care to regenerative medicine, we could not imagine someone better qualified than Cheryl to help guide us through our next phase. As President and CEO of a drug delivery and regenerative medicine company, she understands the path forward and brings to the table considerable experience in corporate strategy, R&D, commercialization, strategic partnerships, regulatory, clinical and quality, operations, manufacturing, marketing, and fundraising. We welcome her insights as we develop and implement our five-year strategic plan to deliver and sustain double-digit revenue growth beginning in 2019 and beyond.”

“This is an exciting time to join the Anika Board,” said Dr. Blanchard. “I have followed Anika’s growth through the years and have a deep appreciation for the Company’s world-class talent, versatile and proprietary technology platform, and diverse commercial portfolio with an exciting pipeline. I look forward to working closely with the Anika team to effect a transformation that continues to deliver solutions to help patients heal naturally and faster and that builds value for its shareholders.”

Consistent with the Company’s commitment to strong corporate governance, the Anika Board is underway in identifying an additional director who will be joining the Board in the coming months.

Dr. Blanchard currently serves as President and CEO of Keratin Biosciences, Inc., a venture-backed biotech company developing regenerative medicine and drug delivery therapies based on a purified human-derived keratin technology platform. She also serves as a director of SeaSpine Holdings Corporation, CeramTec GMBH, Elute, and Bio2 Technologies, is a member of the National Academy of Engineering, and advises a number of venture and private equity clients.

Previously, she served in a number of leadership roles, including Sr. Vice President and Chief Scientific Officer and GM, Biologics, at Zimmer, Inc., a worldwide healthcare leader in the design, development, manufacture and marketing of orthopedic implants.

Dr. Blanchard holds 32 patents, many of which are used in commercial applications, and has over 50 peer-reviewed publications. She holds a Bachelor of Science with Honors in Ceramic Engineering from Alfred University, and a Master of Science and Ph.D. in Materials Science and Engineering, both from the University of Texas at Austin.

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative 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 tissue 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 third paragraph and the fifth 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 future revenue expectations and the composition of the Company’s Board of Directors. 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, including the availability of suitable director candidates. 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, Inc.
Sonal Vasudev, 917-523-1418
sonal@w2ogroup.com

NuVasive Grows Expandable Spinal Interbody Portfolio With Launch Of TLX® 20 Degree Implant

SAN DIEGOSept. 5, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ : NUVA ), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the launch of its TLX® 20 degree expandable spinal interbody implant with a first-of-its-kind oblique profile designed for transforaminal lumbar interbody fusion (TLIF) procedures. This product launch is another step forward in the Company’s strategy to build a comprehensive expandable portfolio to best support optimal clinical outcomes.

The TLX 20 expandable implant’s integrated auto-lock feature allows surgeons to incrementally customize expansion up to 20 degrees of oblique lordosis and tailor implant expansion based on a patient’s clinical need, compared to many expandables in the market which only offer up to 15 degrees of lordosis. The implant profile is designed to optimally contour to a patient’s interdiscal space to help maintain coronal alignment while achieving sagittal correction, an important aspect of desired patient outcomes that has been clinically validated through research and data from NuVasive’s Integrated Global Alignment® (iGA®) platform.

In addition, the TLX 20 degree implant system includes a single, low-profile instrument to position, expand and post-pack the implant with bone graft, improving visualization into the disc space and surgical workflow. The implant also features increased tapering at the distal tip to aid insertion into a collapsed disc space, common among patients with degenerative disc disease, while minimizing the disruption to the surrounding anatomy.

“The TLX 20 system is an innovative device that can improve surgical workflow and patient outcomes by easily and actively enhancing the segmental alignment and interspace height,” said Dr. Christopher Shaffrey, neurosurgeon at University of Virginia Health System. “The compact integrated insertion device makes graduated and precise expansion easy and subsequent graft packing uncomplicated and straightforward in manner. In both open and minimally invasive surgery applications, the TLX 20 facilitates treatment of the entire range of degenerative and deformity conditions requiring interbody instrumentation.”

“The innovative, oblique profile of the TLX 20 degree expandable implant is a true differentiator in the expandable interbody market,” said Matt Link, executive vice president, strategy, technology and corporate development of NuVasive. “With this latest addition, NuVasive continues to offer our surgeon partner’s the most innovative procedurally-integrated portfolio in spine to further their treatment options for patients of varying sizes and clinical needs.”

The NuVasive expandable interbody portfolio now includes three lordotic expandable systems: TLX 15 degree and TLX 20 degree; MLX®, the medial lateral expandable interbody system, which provides an ALIF-sized footprint from a posterior approach; and XLXTM ACR®, the XLIF® lordotic expandable for anterior column realignment, which recently received 510(k) clearance. All are commercially available in the U.S.

About NuVasive

NuVasive, Inc. (NASDAQ : NUVA ) is the leader in spine technology innovation, focused on transforming spine surgery and beyond with minimally disruptive, procedurally-integrated solutions designed to deliver reproducible and clinically-proven surgical outcomes. The Company’s portfolio includes access instruments, implantable hardware, biologics, software systems for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative monitoring service offerings. With over $1 billion in revenues, NuVasive has an approximate 2,400 person workforce in more than 40 countries serving surgeons, hospitals and patients. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

WishBone Medical, Inc. announces new AlloMate Bone Pin System

WARSAW, Ind., Sept. 05, 2018 (GLOBE NEWSWIRE) — WishBone Medical, Inc. announces the official launch of the single-use, sterile packed AlloMate Bone Pin System for the maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis or bone grafts and may also be used to fill a void left after screw removal.

The AlloMate Bone Pin System consists of allograft bone pins and accessory instrumentation for quick, reliable and reproducible bone pin insertion. The complete system will be available in five different individual sizes (2.0mm, 2.5mm, 3.0mm, 3.5mm, and 4.0mm) of sterilized human cortical bone pins & corresponding single-use instruments for convenient insertion. We will launch these various sizes in stages. The 3.0mm is currently available and the 2.5mm will be available soon followed by the 2.0mm and the additional sizes. Our initial market feedback with the 3.0mm system has been extremely positive.

These bone pins are sturdy, easy to handle and can integrate into the patient’s bone to help with the healing process. These sterile packed implants and instruments may potentially reduce the risk of infection and can be accurately trimmed intraoperatively to an appropriate length.

Daniel S. Schulman, D.P.M., helped develop this system and he said, “I have performed well over four hundred foot reconstructive procedures without the use of a metal implant. I can validate that this system will definitely simplify the surgical technique and minimize intra-operative and post-operative surgical complications. Patients are elated when they are told there will be no need for a second surgery to remove potentially painful, broken or even infected hardware.”

Nick Deeter, Chairman of the Board and CEO at WishBone Medical, said, “The AlloMate Bone Pin System does help minimize the need for removal in a secondary operation to remove hardware like stainless steel wires.” Mr. Deeter added, “Minimizing the number or surgeries for kids is very important to us.”

About WishBone Medical, Inc.

WishBone Medical is a Global pediatric orthopedic company, committed to providing anatomically appropriate innovative implants and instruments in sterile packed, single use, disposable kits to prevent infection, reduce overall costs for our customers and achieve the best outcomes for children around the world who are still growing.

For further information, email CustomerService@WishBoneMedical.com or call at 574-306-4006. To learn more about WishBone Medical visit www.WishBoneMedical.com or contact Andrew Miclot, Vice-Chairman and President.

Misonix Reports Record Fourth Quarter and Fiscal Year 2018 Revenue

FARMINGDALE, N.Y., Sept. 05, 2018 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq: MSON) (“Misonix” or the “Company”), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, today reported financial results for the fiscal 2018 fourth quarter and year ended June 30, 2018 as summarized below:

($ in millions) Three Months Ended Year Ended
June 30, June 30,
2018 2017 2018 2017
Revenue $   8.6 $   7.9 $   36.7 $   27.3
Gross Profit $   6.1 $   5.5 $   26.9 $   19.1
GP Percentage – product revenue 70.8 % 69.9 % 70.0 % 69.9 %
Pretax loss from continuing operations $   (1.8 ) $   (1.1 ) $   (2.4 ) $   (2.9 )
Net loss $   (1.8 ) $   (0.4 ) $   (7.6 ) $   (1.7 )
EBITDA (1) $   (1.1 ) $   (0.9 ) $   (0.8 ) $   (1.6 )
Adjusted EBITDA (1) $   (0.2 ) $   (0.3 ) $   4.2 $   (0.5 )
June 30, June 30,
2018 2017
Long Term Debt  $  $
Cash $   11.0 $   11.6

(1) Definitions and disclosures regarding non-GAAP financial information including reconciliations are included on page 6 of this press release.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix stated, “Our fourth quarter and fiscal 2018 top-line financial results mark the conclusion of another year of significant company-wide improvements and growth for Misonix. The ongoing and successful execution of our strategies to aggressively expand our leading ultrasonic medical device platform resulted in a 35% rise in annual revenues to a record $36.7 million, exceeding the high-end of our fiscal 2018 guidance. Record top-line growth drove a 41% increase in annual gross profit, while maintaining our healthy gross margin on product sales of 70%. The significant improvement in our fiscal 2018 top- and bottom-line financial performance reflects the added value we are generating from our growth investments and our continued progress in positioning Misonix for ongoing sustainable growth and future profitability. With the positive operating momentum across our business and a strong balance sheet, Misonix has a solid foundation to continue pursuing a range of near- and long-term growth opportunities that we are confident will deliver enhanced returns for our shareholders.

“The demonstrated clinical benefits of Misonix’s ultrasonic surgical devices are a key driver behind the strong demand for our products and improved competitive position across our domestic and international markets. Robust growth in both consumables and equipment sales drove a 20% increase in product revenue for fiscal 2018. We are also very pleased to see continued double-digit revenue growth in our consumables business, a high-margin recurring revenue stream that brings added predictability to our results. Excluding license revenue, consumables accounted for 81% of total sales for the fiscal fourth quarter and 75% of sales for the full year. And, with over 62,000 surgical procedures performed with Misonix consumables, we exceeded our goal for fiscal 2018 and remain on track to meet or exceed our goal of 100,000 annual procedures world-wide within three years.

“In line with our commitment to radically improve patient outcomes through medical technology innovation, we continued to invest in R&D to support the development of new ultrasonic surgical solutions and products, including our next generation Nexus platform product. We have received an overwhelmingly positive response from physicians who tested early prototypes and have incorporated their feedback to make further enhancements to the Nexus product line, which will be unveiled at the NASS conference in September. Nexus presents a compelling value proposition to hospitals and physicians, allowing Misonix to further penetrate operating rooms by expanding our addressable markets.

“As we pursue the next phase of growth for Misonix, we will continue to focus on actively managing our capital structure, driving sales, improving productivity and increasing efficiencies. We are confident that the direction we are headed in will enable us to meet our goal of enhancing long-term shareholder value as we move through fiscal 2019 and beyond.”

Sales Performance Supplemental Data

($ in millions) For the Quarter Ended For the Year Ended
June 30, Net Change June 30, Net Change
2018 2017 $ % 2018 2017 $ %
Total
Consumables $   7.0 $   5.6 $   1.4 25.5 % $   24.5 $   20.4 $   4.1 20.5 %
Equipment   1.6   2.3  (0.7 ) -29.6 %   8.2   6.9   1.3 17.7 %
License   –   –   –   –   4.0   –   4.0 100.0 %
Total $   8.6 $   7.9 $   0.7 9.5 % $   36.7 $   27.3 $   9.4 34.5 %
Domestic
Consumables $   4.6 $   4.0 $   0.6 16.9 % $   17.7 $   14.9 $   2.8 19.1 %
Equipment   0.3   0.5 (0.2 ) -26.4 %   2.3   1.6   0.7 42.4 %
Total   4.9   4.5   0.4 12.2 %   20.0   16.5   3.5 21.3 %
International
Consumables $   2.4 $   1.6 $   0.8 46.5 % $   6.8 $   5.5 $   1.3 24.5 %
Equipment   1.3   1.8 (0.5 ) -30.4 %   5.9   5.3   0.6 10.4 %
Total   3.7   3.4   0.3 5.9 %   12.7   10.8   1.9 17.5 %
License $ $ $ $    – $   4.0  $ $   4.0 100.0 %

Joe Dwyer, Chief Financial Officer, added, “Our strong fourth quarter and fiscal 2018 financial performance marked continued progress against our strategic initiatives, which led to record revenue as well as positive adjusted EBITDA and cash generated from operations. As a result, we ended the quarter with $11 million in cash while continuing to operate debt free. We remain focused on preserving our strong liquidity position and remain committed to profitably growing the business through investments in organic growth initiatives and select accretive acquisitions that bring complementary capabilities to our product portfolio and generate strong returns for our shareholders.”

“Looking ahead, we expect double-digit top-line growth to continue in fiscal 2019 as we continue to follow the approach we’ve successfully deployed to build the top line, maintain close control of fixed and variable costs and optimize the balance sheet and capital structure. As it relates to revenue guidance, we anticipate product revenue growth in fiscal 2019 to exceed 20%, with gross profit margins of approximately 70%.”

Fiscal Fourth Quarter 2018 Conference Call

Misonix will host a conference call at 4:30 p.m. ET today, Wednesday, September 5, 2018.  Senior management will discuss the financial results and host a question and answer session.  The dial in number for the audio conference call is 888-204-4368 (domestic) or 323-794-2423 (international), conference ID 3913387. Participants may also listen to a live webcast of the call through the “Events and Presentations” section under “Investor Relations” on Misonix’s website at www.misonix.com.  A webcast replay will be available for 30 days following the live event at www.misonix.com.

About Misonix, Inc.

Misonix, Inc. (Nasdaq: MSON) designs, manufactures and markets ultrasonic medical devices for the precise removal of hard and soft tissue, including bone removal, wound debridement and ultrasonic aspiration. Misonix is focused on leveraging its proprietary ultrasonic technology to become the standard of care in operating rooms and clinics around the world. Misonix’s proprietary ultrasonic medical devices are used in a growing number of medical procedures, including spine surgery, neurosurgery, orthopedic surgery, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. At Misonix, Better Matters to us. That is why throughout the Company’s history, Misonix has maintained its commitment to medical technology innovation and the development of ultrasonic surgical products that radically improve patient outcomes. Additional information is available on the Company’s web site at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2017, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking statements.

Contact:
Joe Dwyer
Chief Financial Officer
Misonix, Inc.
631-694-9555
Joseph Jaffoni, Norberto Aja, Jennifer Neuman
JCIR
212-835-8500 or mson@jcir.com

    


Misonix, Inc. and Subsidiaries
Consolidated Statements of Operations
For the years ended
June 30,
2018 2017 2016
Revenues
  Product $   32,669,826 $   27,269,963 $   23,113,194
  License $ 4,010,000 $ $
Total revenue $   36,679,826 $   27,269,963 $   23,113,194
Cost of goods sold   9,794,898   8,217,439   7,640,626
Gross profit   26,884,928   19,052,524   15,472,568
Operating expenses:
 Selling expenses   16,368,381   14,220,907   12,632,961
 General and administrative expenses   9,063,139   9,595,206   6,829,516
 Research and development expenses   4,394,149   1,837,497   1,839,479
Total operating expenses   29,825,669   25,653,610   21,301,956
Loss from operations (2,940,741) (6,601,086) (5,829,388)
Other income (expense):
 Interest income   26,123   75   81
 Royalty income and license fees   525,438   3,771,610   3,948,757
 Other   2,274 (36,211) (21,878)
Total other income   553,835   3,735,474   3,926,960
(Loss) from continuing operations before income taxes  (2,386,906)  (2,865,612) (1,902,428)
Income tax expense (benefit)   5,416,646  (1,022,808) (573,351)
Net (loss) from continuing operations (7,803,552) (1,842,804) (1,329,077)
Discontinued operations:
  Gain from sale of discontinued operations net of tax of
  $58,883, $88,375 and $93,069, respectively   191,117   161,625   156,931
Net income from discontinued operations   191,117   161,625   156,931
Net (loss) $   (7,612,435 ) $   (1,681,179 ) $   (1,172,146 )
Net income (loss) per share:
Continuing operations:
  Basic $   (0.87 ) $   (0.22 ) $   (0.17)
  Diluted $   (0.87 ) $   (0.22 ) $   (0.17)
Discontinued operations
  Basic $   0.02 $   0.02 $   0.02
  Diluted $   0.02 $   0.02 $   0.02
Combined
  Basic $   (0.85 ) $   (0.20 ) $   (0.15 )
  Diluted $   (0.85 ) $   (0.20 ) $   (0.15 )
Weighted average shares – Basic   9,009,189   8,398,778   7,776,949
Weighted average shares – Diluted   9,009,189   8,398,778   7,776,949

  

Misonix, Inc. and Subsidiaries
Consolidated Balance Sheets
June 30,   June 30,
2018   2017
   
Assets  
Current assets:    
Cash and cash equivalents $   10,979,455 $   11,557,071
Accounts receivable, less allowance for doubtful accounts of $200,000 and $96,868, respectively   5,245,549   5,133,389
Inventories, net   5,019,886   4,992,434
Prepaid expenses and other current assets   611,647   918,899
Total current assets   21,856,537   22,601,793
Property, plant and equipment, net of accumulated amortization and depreciation of $9,023,235 and $6,976,282, respectively   4,188,378   3,730,203
Patents, net of accumulated amortization of $1,063,393 and $885,394, respectively   757,447   719,136
Goodwill   1,701,094   1,701,094
Intangible and other assets   517,295   282,876
Deferred income tax   –   4,334,547
Total assets $ 29,020,751 $ 33,369,649
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $   1,794,098 $   1,861,228
Accrued expenses and other current liabilities   2,812,172   3,346,138
Total current liabilities   4,606,270   5,207,366
Deferred lease liability   –   9,354
Deferred income   13,303   13,087
Total liabilities   4,619,573   5,229,807
Commitments and contingencies
Shareholders’ equity:        
Common stock, $.01 par value-shares authorized 40,000,000; 9,430,466 and 9,357,166 shares issued and outstanding in each period   94,305   93,572
Additional paid-in capital   39,772,973   36,808,810
Accumulated deficit (15,466,100 ) (8,762,540 )
Total shareholders’ equity   24,401,178   28,139,842
Total liabilities and shareholders’ equity $   29,020,751   $   33,369,649

Use of Non-GAAP Financial Measures
The Company has presented the following non-GAAP financial measures in this press release: EBITDA and Adjusted EBITDA. The Company defines EBITDA as the net income (loss) as reported under GAAP, plus depreciation and amortization expense, interest expense and income tax expense (benefit). The Company defines Adjusted EBITDA as EBITDA plus non-cash stock compensation expense and engineering costs associated with its development of its next generation platform, which will not be a recurring cost when the project is completed in late 2018.

We present these non-GAAP measures because we believe these measures are useful indicators of our operating performance. Our management uses these non-GAAP measures principally as a measure of our operating performance and believes that these measures are useful to investors because they are frequently used by analysts, investors and other interested parties to evaluate the operating performance of companies in our industry. We also believe that these measures are useful to our management and investors as a measure of comparative operating performance from period to period.

Misonix, Inc. and Subsidiaries
Reconciliation of GAAP Results to Non-GAAP Measures
(unaudited)
         
(in millions) Three Months Ended Year Ended
June 30, June 30,
2018 2017 2018 2017
EBITDA:
Net income (loss) $   (1.8 ) $   (0.4 ) $   (7.6 ) $   (1.7 )
Depreciation and amortization   0.4   0.3   1.4   1.1
Income taxes   0.3  (0.8 )   5.4 (1.0 )
EBITDA $   (1.1 ) $   (0.9 ) $   (0.8 ) $   (1.6 )
Non-cash compensation   0.5   0.5   2.7   1.0
Next generation engineering   0.4   0.1   2.3   0.1
Adjusted EBITDA $   (0.2 ) $   (0.3 ) $   4.2 $   (0.5 )

More articles issued by MISONIX, Inc.
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Earnings Releases and Operating Results

Kuros Biosciences Reports Results for First Half 2018

SCHLIEREN (ZURICH), Switzerland, Sept. 05, 2018 (GLOBE NEWSWIRE) — Kuros Biosciences (SIX: KURN) has delivered on its targets in the first half of 2018, confirming its successful transition into a full-fledged orthobiologics company with scientific, clinical, and commercial excellence in bone regeneration. Kuros has recorded first sales of MagnetOs in the U.S. and in Europe, and commercial rollout continues apace in both regions.

Joost de Bruijn, Chief Executive Officer, said: “We have successfully pursued the new course for Kuros in the first half of 2018, progressing on all fronts. We have realized the first sales from MagnetOs, an important milestone as we focus on the commercial opportunity of cutting-edge orthobiologics, and the commercial rollout is advancing on both sides of the Atlantic. Furthermore, we are driving forward the exciting clinical program with Fibrin-PTH in spinal fusion, which represents a huge commercial opportunity.”

Financial position
Cash and cash equivalents (including financial assets and trade and other receivables) as per June 30, 2018, amounted to CHF 9.7 million, compared with CHF 21.4 million as per June 30, 2017.

Operating expenses decreased to CHF 6.0 million (first half 2017: CHF 7.5 million) primarily due to lower non-cash expenses in connection with share-based payments. Expenses for research and development of CHF 3.1 million (CHF 2.2 million in the first half 2017) are mainly external costs for the preparation of the Phase II study (spine indication) of fibrin PTH, personnel expenses and depreciation of tangible assets. Expenses for general and administrative of CHF 4.1 million contained costs for personnel and other expenses for maintenance and administration. Revenues amounted to CHF 0.3 million (first half 2017: CHF 0.5 million) and originated primarily from a milestone payment related to the agreement with Checkmate. Furthermore, the commercial rollout of MagnetOs recognized its first sales. Other income was CHF 1.1 million (first half 2017: CHF 1.5 million) and mainly consisted of proceeds from sub-lease agreements.

The net loss as per June 30, 2018 amounts to CHF 5.2 million, compared to CHF 7.0 million in the corresponding period in the first half of 2017. The primary reason for the substantial decrease of CHF 1.7 million are a substantial reduction in expenses for share-based payment and income tax effects.

Key figures H1 2018 H1 2017
In TCHF, IFRS
Revenue 274 534
Research and development (3,058 ) (2,211 )
General and administrative (4,112 ) (6,777 )
Other income 1,125 1,522
Net operating costs (6,045 ) (7,466 )
Operating income/(loss) (5,787 ) (6,932 )
Net financial income/(loss) (4 ) (247 )
Net income/(loss) (5,247 ) (6,970 )
Net income/(loss) per share (in CHF) (0.63 ) (1.11 )
Cash and cash equivalents, financial assets and trade and other receivables 9,650 21,417

Events after the reporting period
Kuros will issue 370,000 shares to former Xpand Biotechnology shareholders, a milestone related to the merger and triggered by the important CE mark certification in Europe for MagnetOs Putty, which today allows Kuros to commercialize MagnetOs Putty across Europe.

Outlook
Kuros’s products are advancing according to plan with MagnetOs Putty having received clearance for commercialization in the United States and recently having received CE mark in Europe followed by first commercial sales in the United States and Europe, in June 2018. Kuros is financed to initiate the commercialization of MagnetOs in the US and to prepare for the phase II clinical study of Fibrin-PTH in spine.

For further information, please contact: 
Kuros Biosciences AG
Michael Grau
Chief Financial Officer
Tel +41 44 733 47 47
michael.grau@kurosbio.com

LifeSci Advisors
Hans Herklots
Media & Investors
+41 79 598 7149
hherklots@lifesciadvisors.com

About Kuros Biosciences AG 
Kuros Biosciences is focused on the development of innovative products for tissue repair and regeneration and is located in Schlieren (Zurich), Switzerland and Bilthoven, The Netherlands. The Company is listed according to the International Financial Reporting Standard on the SIX Swiss Exchange under the symbol KURN. Visit www.kuros.ch for additional information on Kuros, its science and product pipeline.

Forward Looking Statements 
This media release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. You are urged to consider statements that include the words “will” or “expect” or the negative of those words or other similar words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include scientific, business, economic and financial factors, Against the background of these uncertainties, readers should not rely on forward-looking statements. The Company assumes no responsibility for updating forward-looking statements or adapting them to future events or developments.

Ortho Regenerative Technologies Inc. Announces CFO Change

KIRKLAND, Quebec, Aug. 31, 2018 (GLOBE NEWSWIRE) — Ortho Regenerative Technologies Inc. (CSE: ORTH) (“Ortho RTi” or the “Corporation”) announces that Benedek (Ben) Simo has been appointed Interim Chief Financial Officer, effective immediately. Mr. Simo succeeds Jo-Anne Piché who is leaving the Corporation to pursue other professional projects.

“Jo-Anne has made many contributions to the Corporation and we wish her all the best in her future endeavors,” said Ortho RTi’s Executive Chairman and CEO, Dr. Brent Norton.  “At the same time, we are excited to have attracted an executive of Ben’s caliber to this position. With his depth of financial experience and proven track record of driving value in financial management, we believe that Ben is ideally suited to serve in this role.”

Mr. Simo has over 15 years of experience in financial management with both private and public companies across a variety of sectors.  Most recently, he was Manager, Financial Reporting at Resolute Forest Products, a NYSE- and TSX-listed global leader in the forest products industry with approximately US$3.5 billion in annual revenues.  Prior to that, he served as Financial Controller at Synchronica Inc, an AIM- and TSX-Venture Exchange-listed developer of next-generation mobile messaging solutions that was acquired by Myriad Group AG in 2012.  Previously, Mr. Simo held financial management positions at TouchTunes Interactive Networks, McCain Foods Limited and Ipex Group.  Mr. Simo earned a bachelor’s degree in economics from McGill University, his MBA from Saint Mary’s University, and has obtained a CPA auditor, CA designation.  

About Ortho Regenerative Technologies Inc.

Ortho RTi is an emerging Orthopaedic and Sports Medicine technology company dedicated to the development of novel therapeutic tissue repair devices to dramatically improve the success rate of sports medicine surgeries. Our proprietary biopolymer has been specifically designed to increase the healing rates of sports related injuries to ligaments, tendons and cartilage. The polymer can be directly placed into the site of injury by a surgeon during a routine operative procedure without significantly extending the time of the surgery and without further intervention. Visit us on the internet at www.orthorti.com.

Caution regarding forward-looking statements

This news release may contain certain forward-looking statements regarding the Corporation’s expectations for future events. Such expectations are based on certain assumptions that are founded on currently available information. If these assumptions prove incorrect, actual results may differ materially from those contemplated by the forward-looking statements contained in this press release. Factors that could cause actual results to differ include, amongst others, uncertainty as to the final result and other risks. The Corporation disclaims any intention or obligation to publicly update or revise any forward- looking statements, whether as a result of new information, future events or otherwise, other than as required by security laws.

For further Information, please contact:

Stephen Kilmer
Investor & Media Relations
647.872.4849
kilmer@orthorti.com

Paragon 28® adds novel syndesmotic repair solution to its robust ankle fracture portfolio – Gorilla® Breakaway Screw System

ENGLEWOOD, Colo.Aug. 31, 2018 /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 that help to streamline procedures, allow surgeons flexibility in technique and approach, and facilitate reproducible results benefitting both the surgeon and patient.

The Paragon 28® Gorilla® Breakaway Screw System was designed to offer surgeons an improved design over traditional screws when used for syndesmotic fixation.

There are inherent challenges in addressing syndesmotic repair including:

  • Providing stable fixation while the syndesmosis heals
  • Soft tissue irritation
  • Screw fracture and removal of fractured implants

The Gorilla® Breakaway Screw System was designed with these challenges in mind. A rigid construct allows the syndesmosis to heal while a low-profile head limits soft tissue irritation. While broken and loose screws have demonstrated improved patient outcomes as compared to intact syndesmotic screws1, the location of screw breakage can be unpredictable with some breakage causing osteolysis from adjacent bony erosion leading to pain and difficult removal.2

The Breakaway Screw System was designed so that if screw fracture occurs, the screw breaks cleanly in the clear space at the notch point. Multiple removal features allow the surgeon to remove the screw fragments medially or laterally, if necessary.

Two notch lengths (14 and 17 mm) were designed to address differences in patient anatomy and to accommodate screw use with or without a plate. The notch is designed to be placed in the clear space when used for syndesmosis repair.

If removal is desired, the tibial component of the Breakaway Screw may be removed medially or laterally utilizing dedicated removal instrumentation.

Paragon 28® is grateful for the significant contributions Dr. John Kwon, MD and Dr. Matthew Riedel, MD have made as the surgeon designers of this system.

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. From the onset, Paragon 28 has made it our goal to re-invent the space of foot and ankle surgery. We believe that through research and innovation we can create new and improved solutions to the challenges faced by foot and ankle specialists.

1. Manjoo A, Sanders DW, Tieszer C, Macleod MD. Functional and radiographic results of patients with syndesmotic screw fixation: implications for screw removal.

J Orthop Trauma. 2010;24:2-6

2. Riedel MD, Briceno J, Miller C, Kwon J Technical tip: Removal of a broken tri-cortical syndesmotic screw using a “perfect circle” technique. Injury. 201 B Apr;49(4):877-880. doi: 10.1 016/j.injury.2018.02.022. Epub 2018 Mar 2.

Product Page:

www.paragon28.com

Contact:

Jim Edson

1-971-4007193

jedson@paragon28.com


SOURCE Paragon 28, Inc.

Photo: PRNewsfoto/Paragon 28, Inc

Related Links

http://www.paragon28.com

Captiva Spines’s TirboLOX-L™ Dual Layer Organic Lattice Structure 3D Printed Titanium Lumbar Cages Receive Clearance

Jupiter, FL, August 2018 – Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its TirboLOX-L 3D Printed Titanium Lumbar Cages.

TirboLOX-L Titanium Lumbar Cages

TirboLOX-L Titanium Lumbar Cages are created using advanced 3D printing technologies to form titanium alloy interbody fusion devices with a dual layer organic lattice structure. This lattice structure features a micro-rough surface topography, interconnected dual porosity, and open architecture.  Titanium alloy implants with micro-rough surface topographies and dual porosity have been shown to promote direct bony ongrowth, ingrowth and vascularization. TirboLOX-L’s open architecture is designed to reduce radiographic presence for clear imaging.  TirboLOX-L’s high coefficient of friction creates immediate bidirectional fixation.

Dennis Ty, Director of R&D of Captiva Spine declared, “With the advanced capabilities of 3D Additive Manufacturing we were able to create a unique lattice structure similar to trabecular bone incorporating a micro-rough surface for clot retention and early osteogenic cell migration, including a dual layer of porosity with pore sizes specifically designed to promote bone ingrowth and vascularization.  Through substantial surgeon design input we are able to deliver TirboLOX-L’s unique dual layer organic lattice structure with numerous geometries and sizes that appeal to a wide range of surgeon preferences.”

Dale Mitchell, President and Founder of Captiva Spine said, “I am pleased our development team was able to incorporate our proprietary Pivotec® Pivoting TLIF Cage into TirboLOX.  Pivotec technology has been used in thousands of surgeries to address the challenges of controlling cage insertion and angle manipulation during surgery and is now available in a wide range of porous Titanium 3D printed, sterile packaged implants. This is especially important during minimally invasive (MIS) applications where time and safety is always of the essence.”

Captiva Spine’s TirboLOX-L Lumbar Cages are one of five new product launches that will be featured at Booth 1649 during the North American Spine Society (NASS) Annual Meeting held in Los Angles, September 26-28, 2018.

Inquiries from tenured distribution professionals looking to partner with a company to build a relationship for the long run are always welcome.

For sales, contact:
Chip Jones, Director of Sales and Marketing
chip.jones@captivaspine.com or 561-277-9480 ext. 725
or via their website www.captivaspine.com/contact-us.

About Captiva Spine, Inc.

As a privately owned medical device organization founded in 2007, Captiva Spine supports spine surgeons, tenured spine distributors, and healthcare facilities in providing patients with progressive spinal care and an obsessive focus on quality.  They strive to create and maintain sincere, honest, collaborative relationships. By valuing their relationships above all else, it fosters the mutual trust and openness needed for Captiva Spine to be a conduit of high quality, smart, elegant, and intuitive patient solutions. As a family of industry professionals, Captiva Spine takes pride in delivering these solutions responsibly and ethically while never losing sight of what they refer to as the Human Factor: Finding the joy in their daily lives and serving the needs of their customers with sincere, professional enthusiasm.

 

This Press Release can be found at PRWeb.com and is also featured on other media outlets.