Mainstay Medical to seek further funding as full-year losses mount

Aug 24, 2017 – Charlie Taylor

Dublin-listed Mainstay Medical, a company that is targeting chronic back pain with an implantable device, is expecting to seek further funding in the near future as it ramps up its commercialisation plans.

The medical devices firm, which recently announced it had passed the mid-point in clinical trials in the US, made its first commercial sale earlier this year in Germany.

Mainstay’s ReActiv8 product is implanted in a surgical procedure and works by using electrical stimulus of nerves in muscles supporting the lower spine. The product won European approval last year after which it raised €30 million in funding to commercialise ReActiv8.

Speaking to The Irish Times, chief executive Peter Crosby said it was looking at various options in terms of additional fundraising.

“We know we will need more capital to complete the US trial and to get pre-market approval. We’ll also need more to drive commercialisation, but we haven’t given any indication yet on how much we’ll be looking for or when,” said Mr. Crosby.

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Exclusive Agreement to Co-market Proprietary Software Platform to Aid in Total Hip Replacement Announced Between DePuy Synthes and JointPoint, Inc.

WARSAW, Ind.Aug. 24, 2017 /PRNewswire/ — Today, DePuy Synthes* announces an exclusive U.S. agreement with JointPoint, Inc. to co-market its proprietary software platform to provide an easy-to-use, surgeon-friendly navigation system that can help deliver improvements in surgical outcomes. JointPoint’s software provides non-invasive computer navigation, pre-surgical digital templating, case planning, and feedback while performing total hip replacement surgeries. JointPoint easily integrates with the Anterior Approach. The Anterior Approach is a minimally invasive surgical approach that allows a surgeon to work around the muscles, rather than cut through them, to get to the hip joint.

Adding the JointPoint software to a surgeon’s protocol may help reduce leg length discrepancy and complications related to inaccurate cup placement and final implant selection – two of the most important considerations in hip replacement surgery – by providing pre-surgical digital templating and real-time, data-driven surgical decision making in the operating room.

“We are thrilled to partner with JointPoint to help provide more predictive outcomes for surgeons and their patients,” said Aaron Villaruz, Global Hip Platform Leader, DePuy Synthes Joint Reconstruction. “By providing access to important information at key stages of the hip replacement process, together we can help surgeons streamline cases and allow for pre-surgical goals to be achieved more consistently.”

One of the important features of the JointPoint software is OneTrial™, which can predict optimal implant combinations based on pre-surgical goals using just two images during surgery. Unique to DePuy Synthes implants is the ability of OneTrial™ to also provide precise recommendations on implant size and position to enable more confident adjustments and reduce OR time and fluoroscopy by eliminating re-trialing. Additionally, the JointPoint software helps streamline communications through a JointPoint calendar, case sharing, and case planning/collaboration.

“During hip replacement surgery, physicians strive for optimal implant choices and positioning to improve patient satisfaction by achieving proper leg length, offset, and cup positioning. JointPoint Hip Navigation System gives surgeons the confidence with real time feedback so they can ultimately help restore patients back to their natural function efficiently while minimizing fluoroscopy,” said Dr. Andrew J. Cooper**, MD. “I’m excited about what JointPoint can offer those surgeons whose patients are good candidates for the Anterior Approach.”

DePuy Synthes will begin co-marketing the JointPoint software in the second half of 2017.

About DePuy Synthes Companies

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

About JointPoint, Inc.

JointPoint, Inc. develops and markets software-driven medical technology for orthopaedics. The JointPoint software solution and OneTrial™ technology is a completely non-invasive navigation system for hip replacement surgery that provides intraoperative data and guides component selection while also optimizing efficiency within a surgical workflow. For more information, visit http://www.jointpoint.com

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**Consultant to DePuy Synthes Joint Reconstruction with an ownership interest in JointPoint, Inc.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

Photo courtesy of JointPoint, Inc.

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

 

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

Peninsula Orthopaedic Associates Announces First MACI Implant in the Region for the Treatment of Cartilage Defects of the Knee

SALISBURY, Md.Aug. 24, 2017 /PRNewswire/ — POA, a large regional orthopaedic specialty group, announced their first successful implant of MACI® (autologous cultured chondrocytes on a porcine collagen membrane) in the region. MACI is an FDA-approved product, in which a patient’s own cartilage cells from the knee are regrown in a laboratory and implanted back into the patient’s knee to repair the defect.

With the introduction of MACI, surgeons now have an FDA approved product in which the patient’s own cells can be reproduced in a controlled lab environment, embedded on a special collagen membrane, and then implanted in the knee using a minimally invasive technique. “Joint preservation surgery has undergone its next evolution.  With this new technology, we can use a patient’s own cells to grow new cartilage to preserve their joint.  The scaffold which delivers their cells allow for minimally invasive surgery and smaller incisions.  We are working on an all-arthroscopic technique, as well.  While this operation will not work for an arthritic knee, it has the promise of preserving a knee and potentially preventing future arthritis,” says Orthopaedic Surgeon Dr. Jason Scopp.

About MACI

MACI® (autologous cultured chondrocytes on a porcine collagen membrane) is an autologous cellular scaffold product that is used in the repair of symptomatic single or multiple full-thickness cartilage defects of the knee, with or without bone involvement in adults. The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from a patient’s own cartilage for the manufacturing of MACI. The FDA approval of MACI was supported by the results of SUMMIT trial, a Phase 3 two-year trial.

About POA

Peninsula Orthopaedic Associates is a multi-specialty orthopaedic practice with offices in Berlin and Salisbury, Marylandand Millsboro and Seaford, Delaware. With over 50 years of providing comprehensive orthopaedic care, we provide expertise in foot and ankle, hand, hip and knee, shoulder and elbow, spine, sports medicine, joint replacement, joint preservation, orthopaedic trauma care, performance enhancement and rehabilitation, and biologic solutions, in order to offer an expansive continuum of care for our region.

For more information, please visit the MACI website at maci.com, or contact Jessica Ennis at
410-860-4506 or jennis@peninsulaortho.com.

SOURCE Peninsula Orthopaedic Associates

Bone Biologics Adds Osteoporosis and Trauma Indications to its Portfolio

August 23, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics Corp (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, today has announced that it has expanded its Field of Use definition of the license agreement with the UCLA Technology Development Group on behalf of UC Regents for NELL-1. Additionally, Bone Biologics has entered into an exclusive license agreement with the UCLA Technology Development Group on behalf of UC Regents for the worldwide application of the NELL-1 protein for both osteoporosis and trauma through a technology transfer.

“Following the completion of several key milestones, Bone Biologics is pleased to include two additional indications to its portfolio,” said Stephen LaNeve, CEO and President of Bone Biologics. “In addition to the company’s work in spine fusion, this exclusive license agreement for trauma and osteoporosis, further supports the possibility of NELL-1 becoming a proprietary platform technology.”

Most current osteoporosis therapies are designed to slow bone loss and prevent it from worsening but research involving NELL-1 is being examined to systemically restore bone and prevent further loss.

About Bone Biologics

Bone Biologics (OTC: BBLG) was founded to pursue regenerative medicine for bone.

Bone Biologics Corporation is undertaking groundbreaking work and building on unprecedented research on the NELL-1 molecule that has produced a significant number of studies and publications in peer reviewed scientific literature.

Bone Biologics is currently focusing its development efforts for its bone graft substitute product on bone regeneration in spinal fusion. NELL-1 is a recombinant human protein growth factor that is essential for normal bone development.

For more information, please visit the company’s website at www.bonebiologics.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s expectations with respect to trading in the Company’s common stock on the OTC; the next phase of the Company’s development and testing work; the Company’s expectation about moving its technology forward and setting the stage for future growth and enhanced shareholder value; and the future need for regenerative bone solutions. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of the Company and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: future revenues, expenditures, capital or other funding requirements, the adequacy of the Company’s current cash and working capital to fund present and planned operations and financing needs, expansion of and demand for product offerings, and the growth of the Company’s business and operations through acquisitions or otherwise, as well as future economic and other conditions both generally and in the Company’s specific geographic and product markets. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent current report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2017 and Form 10-Q, filed with the Securities and Exchange Commission on August 8, 2017. The Company anticipates that subsequent events and developments may cause their views and expectations to change. The Company assumes no obligation, and they specifically disclaim any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

ChoiceSpine™ Successfully Completed 1,000th TOMCAT™ ACDF Procedure

ChoiceSpine LP, a privately-held spinal device manufacturer based in Knoxville, TN, successfully completed its 1,000th TOMCAT Anterior Cervical Discectomy and Fusion (ACDF) procedure. The procedure was performed by Julian Price, MD of Athens Orthopedic Clinic, Athens, GA at St. Mary’s Hospital, also in Athens, on August 14, 2017.

“I choose to use TOMCAT for all my ACDF procedures as it provides streamlined implantation with modular instruments, self-locking retention clip and a hybrid device that eliminates difficult screw trajectories.” stated Dr. Price. “My clinical outcomes with TOMCAT are excellent as I have experienced early bone growth with the Hydroxyapatite (HA) Enhanced integrated PEEK™ spacer.”

The TOMCAT Cervical Spinal System was designed to stabilize and fuse the cervical vertebral column with no profile or low profile anteriorly. TOMCAT is available in two configurations, Zero Profile and Hybrid, both with 4° and 8° lordosis. The Zero Profile, Stand Alone TOMCAT sits within the vertebral body leaving the anterior cervical spine unchanged, which may reduce post–operative complications for good healing. The Hybrid, Stand Alone TOMCAT provides an adaptable surgical solution when previous adjacent level treatment is present. Both devices provide an optimized fusion environment with large, center chambers for bone graft and HA-enhanced PEEK that provides early bone apposition.

“This is an important milestone for TOMCAT and ChoiceSpine. The 1,000th completed TOMCAT procedure continues our successful track record of delivering products that produce quality outcomes in spine surgery,” said Rick Henson and Marty Altshuler, co-founders of ChoiceSpine. “TOMCAT’s flexible design allows it to adapt to complex cervical anatomy providing spine surgeons with one solution to address multiple surgical challenges during ACDF procedures.”

About ChoiceSpine 
ChoiceSpine is a privately-held spinal device company located in Knoxville, TN. The Company prides itself on providing excellent products and exceptional service to meet the needs of their customers. ChoiceSpine offers a breadth of innovative and surgeon-focused systems that are designed to be safe, efficient and easy-to-use. By working closely with physicians and maintaining a service-focused distribution, ChoiceSpine will continue to bring technically-superior spinal products to market.

Contact:
KC Gilbert
Vice President Marketing & Professional Education
865-246-3333
kgilbert(at)choicespine(dot)com
choicespine.com

Misonix Appoints Joseph Dwyer as Chief Financial Officer

FARMINGDALE, N.Y., Aug. 23, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today that Joseph P. Dwyer has been appointed as Chief Financial Officer. Mr. Dwyer has been serving as Interim Chief Financial Officer of Misonix since September 2016.

Stavros Vizirgianakis, President and Chief Executive Officer of Misonix, said, “I am pleased to officially welcome Joe as our Chief Financial Officer. His background is well suited to provide Misonix with financial leadership along with his dedication to the success of our business. Joe has been intimately involved with our audit committee, working through the financial and regulatory challenges of the past year and his financial background was instrumental in bringing us through those challenges. I am confident that his broad base of financial and operational experience will prove to be advantageous in growing our business both domestically and internationally.”

Joe Dwyer brings to Misonix a strong track record of accomplishments with more than 20 years of senior level finance experience. From June 2015 he has provided financial consulting and advisory services to various companies through the firms Dwyer Holdings and TechCXO. Prior thereto, from November 2012 until June 2015, he was Chief Financial Officer of Virtual Piggy, Inc., a publicly-traded technology company. Prior to joining Virtual Piggy, Mr. Dwyer served as chief financial officer of OpenLink Financial, Inc., a privately held company, which provides software solutions for trading and risk management in the energy, commodity, and capital markets. During 2011 and 2012, Mr. Dwyer was a member of the board of directors and chairman of the audit committee and served as interim chief administrative officer of Energy Solutions International, Inc., a privately-held company providing pipeline management software to energy companies and pipeline operators. From 2010 through 2011, Mr. Dwyer served as chief administrative officer of Capstone Advisory Group, LLC, a privately- held financial advisory firm providing corporate restructuring, litigation support, forensic accounting, expert testimony and valuation services. Mr. Dwyer served as a consultant to Verint Systems, Inc., a software company listed on the NASDAQ Global Market, from 2009 through 2010, assisting with SEC reporting and compliance. From 2005 through 2009, Mr. Dwyer served as chief financial officer and executive vice president of AXS-One Inc., a publicly traded software company. During 2004, Mr. Dwyer served as chief financial officer of Synergen, Inc., a privately held software company providing energy technology to utilities. Prior to 2004, Mr. Dwyer also served as chief financial officer and executive vice president of Caminus Corporation, an enterprise application software company that was formerly listed on the NASDAQ National Market, chief financial officer of ACTV, Inc., a digital media company that was formerly listed on the NASDAQ National Market, and senior vice president of finance for Winstar Communications, Inc., a publically traded telecommunications company.

Mr. Dwyer received his BBA in Accounting from the University of Notre Dame in 1978 and is licensed as a Certified Public Accountant in the State of New York.

About Misonix
Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’sproprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website 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, 2016, 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.

Corporate Contact
Joe Dwyer
Misonix, Inc.
631-927-9113
jdwyer@misonix.com

Investor Contact
Joe Diaz
Lytham Partners
602-889-9700
mson@lythampartners.com

Misonix, Inc.

SI-BONE, Inc. Announces Highmark, Inc., 4th Largest BCBS Plan & 10th Largest Commerical Payor, Establishes Coverage Policy for MIS SI Joint Fusion IFuse Implant System

SAN JOSE, Calif.Aug. 23, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (iFuse), a triangular-shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Highmark, Inc., the nation’s 4th largest Blue Cross and Blue Shield-affiliated insurer, has established an exclusive positive coverage policy for MIS SI joint fusion using the iFuse Implant System.  Highmark, Inc., an independent licensee of the Blue Cross and Blue Shield Association, is among the top 10 largest health insurers in the United States and includes Blue Cross Blue Shield (BCBS) of Pennsylvania, BCBS of Delaware and BCBS of West Virginia.

Based on the more than 50 peer-reviewed clinical studies and publications, the policy, available at the link below, provides iFuse coverage for more than 4.5 million Blue Cross Blue Shield plan members in PennsylvaniaDelaware and West Virginia effective August 21, 2017.

https://secure.highmark.com/ldap/medicalpolicy/wpa-highmark/S-230-010.html

The Following Blue Cross Blue Shield Plans now cover iFuse:

  1. BCBS of Texas: HCSC: Exclusive to iFuse
  2. BCBS of Oklahoma: HCSC: Exclusive to iFuse
  3. BCBS of New Mexico: HCSC: Exclusive to iFuse
  4. BCBS of Montana: HCSC: Exclusive to iFuse
  5. BCBS of Illinois: HCSC: Exclusive to iFuse
  6. BCBS of Pennsylvania: Highmark: Exclusive to iFuse
  7. BCBS of Delaware: Highmark: Exclusive to iFuse
  8. BCBS of West Virginia: Highmark: Exclusive to iFuse
  9. BCBS of Michigan
  10. BCBS of Vermont
  11. BCBS of Nebraska

Over 22.5 million BCBS health plan members are now covered for MIS SI joint fusion.

“The SI joint is a common source of low back pain in many patients. I have performed over 90 procedures with the iFuse Implant System and it has been a rewarding procedure for my patients and for me as a spine surgeon.  I am very pleased to now be able to offer appropriately diagnosed Blue Cross Blue Shield patients this clinically proven SI joint fusion procedure,” said Michael Oh, MD, neurosurgeon at Allegheny General Hospital in Pittsburgh, PA.

“For almost 10 years, we have been keenly focused on building products and an effective procedure that benefits patients who have SI joint disruption and/or degenerative sacroiliitis. We are of course pleased that Highmark has decided to provide coverage based on the extensive published data demonstrating safety, clinical effectiveness, durability, low revision rates and opioid user reduction of the iFuse Implant System that has been available since 2008,” said Jeffrey Dunn, President, Chairman and CEO at SI-BONE.

About SI joint dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5 Like all other major joints, the SI joint can be injured or degenerate, which can cause debilitating pain in the lower back, buttocks and legs.  Simple movements such as standing up, sitting down, stepping up or down, bending and lifting, walking, or even sleeping or sitting on the affected side can provoke a symptomatic SI joint.

SI joint dysfunction is often misdiagnosed and the resulting pain can be misattributed to other causes.  Not all healthcare providers evaluate the SI joint and many patients do not know to ask about it. While not commonly diagnosed, SI joint disorders can be identified when a patient points to their source of pain directly over the posterior superior iliac spine (PSIS) known as the Fortin Finger Test, combined with a number of positive provocative maneuvers to stress the SI joint and elicit the pain, followed by image-guided diagnostic injections.

The other major joints in the human body, such as knees, hips, ankles and shoulders, have specialized device-based surgical solutions.  The SI joint is the largest and the last of eight major joints in the human body to have a proven surgical solution.  The iFuse Implant™ was designed specifically to withstand the extreme forces resulting from load-bearing and the unique rotational and translational motion of the SI joint referred to as nutation, and is supported by more than 50 peer-reviewed publications including two Level 1 randomized controlled trials.

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading medical device company that has developed the iFuse Implant System, a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint to treat common disorders of the joint that can cause lower back pain.  Patients with sacroiliac joint dysfunction experience pain that can be debilitating.  SI-BONE believes that the sacroiliac joint is the last of the eight major joints in the human body to have a proven surgical treatment and that the iFuse Implant, first FDA-cleared in 2009, is the only device for treatment of SI joint dysfunction supported by significant published clinical evidence, including level 1 trials, showing safety and durable effectiveness, including providing lasting pain relief.

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis.  This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9752.08232017

  1. Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.
  2. Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.
  3. Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.
  4. Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
  5. DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com

Bone Biologics Completes $1.4 Million Round of Financing

August 22, 2017

BURLINGTON, Mass.–(BUSINESS WIRE)–Bone Biologics (OTC: BBLG), a developer of orthobiologic products for domestic and international spine fusion markets, announced today the completion of a $1.4 million funding round with Musculoskeletal Transplant Foundation and Hankey Capital, LLC. The funding represents the first round of a previously announced private placement. Proceeds will be used for working capital, protein development, laboratory and testing equipment necessary to support such development, regulatory and clinical expenses, and development work to extend the patent life of NELL-1, as well as for other purposes not presently contemplated herein but which are related directly to growing the Company’s current business, research and development activities

The securities offered have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the Securities Act and applicable state securities laws.

Forward-Looking Statements

This press release contains forward-looking statements that reflect the Company’s current beliefs, expectations or intentions regarding future events. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “will,” “will be,” “anticipate,” “predict,” “continue,” “future,” and similar expressions are intended to identify such forward-looking statements.

Disclaimer

This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which the offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

Contacts

Bone Biologics
Jeff Frelick, Chief Operating Officer
jfrelick@bonebiologics.com
or
Compass Investor Relations
Mark Collinson, 714-222-5161
mcollinson@compass-ir.com
or
Media Inquiries:
Tracy Williams, 310-824-9000
tracy@olmsteadwilliams.com

Misonix Reports Fiscal Year 2017 Financial Results

FARMINGDALE, N.Y., Aug. 22, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the fourth quarter and fiscal year ended June 30, 2017.

Financial Highlights for the Fourth Quarter and the Full Year:

  • Revenue for fiscal year 2017 was $27.3 million, an increase of 18% compared with $23.1 million in fiscal 2016. For the fourth quarter, net sales increased 23% to $7.9 million compared with $6.4 million in the fourth quarter of fiscal 2016.
  • Domestic sales in fiscal year 2017 increased 26% to $16.5 million versus $13.1 million in fiscal 2016. For the fourth quarter of fiscal 2017, domestic sales increased 18% to $4.4 million compared with $3.8 million in the fourth quarter of 2016.
  • Consumables sales in the United States increased 32% to $14.9 million for fiscal year 2017 compared with $11.3 million in fiscal 2016.
  • The gross profit margin for the fiscal year was 69.9% primarily from a strong mix of higher margin consumables, compared to 66.9% in fiscal year 2016. Fourth quarter gross profit margin was 69.9% versus 68.0% in the fourth quarter of fiscal 2016.
  • For the fiscal year, operating expenses increased by $4.4 million to $25.7 million driven in part by professional fees relating to the recently completed internal investigation, along with higher sales commissions related to increased sales volume.
  • For fiscal year 2017, the Company reported a net loss of $1.7 million, or $(0.20) per diluted share, compared with a net loss of $1.2 million, or $(0.15) per diluted share, in fiscal year 2016.
  • At June 30, 2017, the Company had cash of $11.6 million with no long-term debt.

Stavros Vizirgianakis, president and chief executive officer of Misonix, said, “We concluded fiscal 2017 on a strong note with fourth quarter revenue increasing 23%, and 18% for the full year as our recurring revenue business model continues to gain traction. Consumables sales, which we define as recurring revenue, accounted for approximately 75% of total sales. Gross margin for the fiscal year was 69.9% up from 66.9% in the previous year.

“Our U.S. business, which we believe offers the best opportunity for growth, grew 26% on a year-over-year basis and accounted for 60% of total revenue. We are making sustainable progress in reigniting the Misonix growth engine.

“One of the contributing factors in the growth of fiscal 2017 revenue has been the addition of new Clinical Sales Specialists to support the sales activities of our distribution channel. Although the second half of the fiscal year is traditionally the strongest for our business, the additional support provided to our distributors generated strong double-digit revenue increases in both the third and fourth quarters of fiscal 2017. We are pleased with the progress achieved to this point.”

Mr. Vizirgianakis continued, “On the international front, we are making necessary changes in distributors and personnel to operate the business more efficiently. Going forward, we will focus on contracting with in-country distributors in the key markets where we believe we can build sustainably growing operations that adhere to single-use of consumable products in surgical procedures.

“As we move ahead, we are working to create a new results-oriented culture within the Company. We have simplified our sales compensation plan with the goal of getting everyone on equal footing and pursuing common goals. In fiscal 2017 Misonix consumables products were used in more than 50,000 surgical procedures worldwide. We have set an aggressive goal of having Misonix consumables products utilized in 100,000 annual surgical procedures worldwide within the next three years. We are dedicated to achieving that goal.

“We enter the new fiscal year with a strong cash position, in excess of $11 million, and no long-term debt. We look forward to the opportunities ahead in fiscal 2018.”

Conference Call
The Company has scheduled a conference call for Tuesday, August 22, 2017, at 4:30 pm ET to review the results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10111207. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

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, 2016, 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.

CoreLink’s Stackable Guide Wire Reduces Potential Risk of SI Joint Fusion

August 22, 2017

ST. LOUIS–(BUSINESS WIRE)–CoreLink, LLC, a fast growing designer and manufacturer of spinal implant systems, announced the release of the Scaltoff™ Wire, a patent pending, stackable guide wire for its Entasis® Sacroiliac Joint Fusion System. The convertible length wire enables constant control during drilling, tapping, and insertion steps yet can be quickly shortened to accommodate the C-arm in lateral view x-rays.

“The most significant threat to patient safety in lateral SI joint fusion procedures is the possibility of the guide wire advancing into the sacral foramina and potentially damaging a nerve root,” says Dr. Donald Sachs (Neurosurgeon, Tampa, FL), “This is a good response to that common risk. Plus, with this, you don’t have to remove the wire, avoiding the frustrations of finding your path again.”

The stackable Scaltoff Wires (blunt and trocar) thread onto and off each other, end-to-end, providing adjustable length. Considered to be the stiffest on the market, the extra rigidity of these stainless steel wires further enhances control for the surgeon.

Now a little more than a year on the market, CoreLink’s Entasis© SI Joint Fusion System has seen more than 500 devices implanted. Surgeons most often cite the device’s Easy-In™ dual-pitch compression threading and the autograft self-harvesting circumferential fenestrations as the most compelling features in their choice of this device. CoreLink expects the addition of the stackable Scaltoff Wire to further accelerate the adoption of this implant system.

For more information or distribution opportunities concerning the Entasis® SI Joint Fusion System, or any of CoreLink’s other spinal implant products, please, visit www.corelinksurgical.com.

About CoreLink

CoreLink, LLC internally designs and manufactures more than 99% of its broad portfolio of spinal implant systems. CoreLink leverages this expertise through collaboration and a dedication to empowering surgeons with the highest quality and most effective instruments and implants possible. That is how CoreLink came to be known as The Source.

Be a part of something. Come to The Source.

Indications for Use

The Entasis Dual-Lead Sacroiliac implant system is intended for sacroiliac joint fusions for conditions including degenerative sacroiliitis and sacroiliac joint disruptions.

Contacts

CoreLink, LLC
Matthew Linhardt, 888-349-7808
Senior Director, Marketing
m.linhardt@corelinksurgical.com