Tyber Medical Announces the Limited Release of the Sterile Comprehensive Forefoot Procedure Kit

BETHLEHEM, Pa.March 21, 2018 /PRNewswire/ — Tyber Medical, LLC, a privately held company focusing on developing innovative medical devices for private label opportunities and advancing the science of bioengineered surfaces, announces the limited release of the Forefoot Procedure Kit.

Tyber Medical is excited to announce the limited release of the Forefoot Procedure Kit. This innovative system is the first efficiency kit on the market to incorporate room setup disposables, instruments for soft tissue, bone and implant preparation, and the corresponding implants. The system configuration allows for flexibility in the treatment of a wide range of fixation procedures including bunion corrections, hammertoes, Aikens as well as Weil’s osteotomies. This unique one of kind system is provided sterile to increase efficiency in the Operating Room.

The complete kit eliminates the necessity for cleaning, decontamination, sterilization, and reprocessing thereby reducing direct and indirect costs while accelerating room turnover to create a more efficient center.  All implants are sterile, ready-to-use, and include headed or headless screws, TyFix™ hammertoe screws, snap-off screws, as well as NiTiNOL staples in various sizes to suit any type of Forefoot procedure.

Catye Mullens, a Certified Surgical Technician in Materials Management at Wilshire Surgery Center and a member of the design team stated, “The Forefoot Procedure Kit is a time saver for OR setups and comes with all the fundamental items we need and nothing we don’t. We also appreciate the efficient space management design which minimizes shelf requirements for our surgery center.”  Donna Faillace, a Certified Surgical Technician at Providence Health Center commented “The Forefoot Procedure Kit makes it so easy to set up for surgeries knowing everything our surgical team and center needs is included.  It decreases turnover time because you’re not waiting for instruments to process and the surgeon is pleased because he has consistent equipment available for every case.”

“The Forefoot Procedure Kit was designed to be an inclusive system delivering a procedure in a box while allowing the surgeon flexibility to create any type of Forefoot reconstructive procedure. The kit aligns efficiency and effectiveness together to offer a solution for cost reduction, time efficiencies, and better organization of pre-operative planning,” commented Jeff Tyber, CEO of Tyber Medical.

Tyber Medical continues to focus on systems designed to drive pre-operative, intra-operative, and post-operative efficiency, while embracing system improvements that could lead to a lower rate of surgical field contamination and subsequent patient infections.  Please visit Tyber Medical’s Booth #333, at ACFAS in Nashville, TN where the company will showcase the Forefoot Procedure Kit and recently released TyFix™ System as well as other innovative products available for private labeling.

About Tyber Medical, LLC.

Tyber Medical, LLC is an orthopedic device manufacturer providing rapid access to portfolio enhancing, regulatory approved, orthopedic implants within the spine and extremity/trauma markets.  While focusing on rapid product commercialization, the company distributes products via private labeling; releasing 14 spine and 25 extremity/trauma systems since its founding in 2012.  Tyber Medical utilizes the differentiated, bioengineered technology such as TyPEEK® osteoconductive coatings and BioTy™, a new antimicrobial nano-textured surface modification to enhance the company’s growing portfolio.

Eric Dickson
83 South Commerce Way, Suite 310
Bethlehem PA 18017
(610) 849-1710

SOURCE Tyber Medical, LLC

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Life Spine Announces FDA Clearance of PLATEAU®-LO Insert and Rotate Spacer System

March 20, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today that the U.S. Food and Drug Administration (FDA) has given 510(k) marketing clearance to the PLATEAU-LO Insert and Rotate Spacer System.

“PLATEAU-LO is my go-to spacer for micro-invasive lumbar interbody fusions. The oblique lordosis and vast array of footprints cater to the wide variety of patient anatomies I see in my practice. I also find that the bulleted tip allows for very simple insertion, and the insert and rotate feature allows for restoration of disc height. These features are essential for good patient outcomes,” said Rebecca Kuo, MD of Joliet, IL.

“PLATEAU-LO is another great addition to our already robust interbody platform. By combining PLATEAU-LO with our AVATAR® Percutaneous Screw System and the CENTRIC®-T Pedicle-Based Retractor System it shows our keen interest in innovation around micro-invasive procedures and providing our customers with multiple options for optimal patient care,” said Mariusz Knap, Vice President of Marketing and Business Development for Life Spine.

PLATEAU-LO is available in PEEK material and is offered in 7° and 12° lordosis and multiple footprints options.

Key Features and Benefits of the system are:

  • Chamfered corners allow for ease of insertion and distraction
  • Oblique lordosis to better match patient anatomies and pathologies
  • Bullet tip simplifies insertion
  • Large, open graft windows maximize visibility and bone graft containment
  • Aggressive tooth pattern prevents graft migration

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.


Life Spine
Omar Faruqi
Chief Financial Officer

Centinel Spine Announces Partnership with PGA Tour Winner Brian Gay

NEW YORKMarch 20, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that it has entered into an endorsement agreement with four time PGA Tour Winner, Brian Gay.  This partnership brings together two leaders in their field, with the goal of educating high performing individuals that spinal injury and disease does not require living with pain or negatively affect an active lifestyle.  This collaboration will demonstrate to patients throughout the world that the lumbar and cervical products provided by Centinel Spine have the potential to give them back their life.

Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year global clinical history of success behind these devices for treatment of degenerative disc disease.  The company recently announced the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio. The prodisc line of products represents the most extensive total disc replacement (TDR) portfolio in the world with the longest history of use.  The acquisition is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms.

The partnership with PGA Tour golfer Brian Gay opens up a new type of athlete and patient population that Centinel Spine Chairman & CEO John Viscogliosi can reach and educate.  “Centinel Spine’s mission is to address spinal disease and allow individuals to continue to function at a high level, even after major spine surgery,” said Viscogliosi.  “The prodisc system was purposefully designed to allow patients to return to their lives faster and with the peace of mind that the implant will restore natural motion for the long-term.  Centinel Spine is proud to be partnered with Brian Gay.”

“I was in constant pain.  It started to affect my daily life and I was unable to play golf.  My doctor told me I had two options, a fusion or a total disc replacement. I knew I wanted a total disc replacement in order to maintain my range of motion and continue to function at a high level,” said Brian Gay.  “As a professional golfer, I had confidence in the Centinel Spine prodisc system based on its inherent stability and long term history of success.  Stability was especially important considering my extensive physical activities.  The fact that prodisc has been implanted for nearly 30 years without any major issues helped make for an easy decision.”

Spine surgeon Robert L. Masson M.D. (Masson Spine Institute, Orlando FL) specializes in complex spinal disorders and reconstructed Brian’s spine using the Centinel Spine prodisc Total Disc Replacement system.  Dr. Masson is a passionate advocate for extreme recovery from spinal injury and is committed to helping his patients achieve full return to all of life’s activities after spinal surgery.  “Brian came to me with excruciating and disabling pain and understood that return to the highest level of golf meant a disc replacement solution along with a commitment to rigorous rehabilitation,” Masson said.  “The prodisc system is a spine reconstruction solution that preserves patient functionality and returns patients like Brian to the highest level of activity.”

In 2018-2019, Brian will be wearing the Centinel Spine logo on his apparel and golf bag at PGA tour events worldwide, and his image and likeness will be utilized in Centinel Spine marketing material.  For updates on Centinel Spine, you may visit our web site (www.CentinelSpine.com) or other social media outlets.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No-Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc® Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use.  For more information on Centinel Spine products and technologies, please visit the Company’s website at www.CentinelSpine.com.

The company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

SOURCE Centinel Spine, LLC

Exactech’s Vitamin E Acetabular Polyethylene Liner for Hip Replacement Gains FDA 510(k) Clearance

March 20, 2018

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Novation XLE Vitamin E acetabular polyethylene liners for hip replacement surgery. These liners are designed to work in conjunction with the Novation® Crown Cup® Acetabular System including InteGrip® printed, 3-D porous material.

The advanced bearing material in the new XLE liners is designed for low wear and contains vitamin E. Oxidation in-vivo can contribute to polyethylene degradation in orthopaedic implant polyethylene. Vitamin E, a natural antioxidant, is blended into the raw material of Novation XLE liners to mitigate oxidative effects both before and after implantation.

This product complements Exactech’s Hip product family, which also includes the Alteon® HA Femoral StemTapered Wedge Femoral StemNeck Preserving Stem and Monobloc Revision Stem.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.


Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Zimmer Biomet Appoints Coleman N. Lannum as Senior Vice President of Investor Relations

WARSAW, Ind.March 19, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that Coleman (Cole) N. Lannum has been appointed Senior Vice President of Investor Relations, reporting directly to the Company’s President and CEO, Bryan C. Hanson.

Mr. Lannum joins Zimmer Biomet with more than 15 years of Investor Relations (IR) experience in the healthcare industry. Most recently, he served as Senior Vice President of Investor Strategy and Investor Relations Officer for Mallinckrodt Pharmaceuticals, where he consulted with executive management and the Board of Directors regarding the Company’s acquisitions, strategic direction and shareholder value optimization.

Prior to joining Mallinckrodt in 2015, Mr. Lannum led IR at Covidien and Tyco Healthcare for nine years.  As Vice President and Investor Relations Officer, he designed Covidien’s IR program, oversaw the largest-ever healthcare Initial Public Offering and led the IR effort through the company’s merger with Medtronic in 2015.

Mr. Lannum’s leadership at Covidien and Mallinckrodt has been recognized with numerous best-in-class honors, including an unprecedented five consecutive awards by IR Magazine for both Best US Investor Relations Officer – Large Cap and Grand Prix – Best Overall Investor Relations from 2011 through 2015.

About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com, or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.


SOURCE Zimmer Biomet Holdings, Inc.

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KFx Medical, LLC Announces Another and Fourth License of its Knotless Double Row Patents

March 19, 2018

SAN DIEGO–(BUSINESS WIRE)–KFx Medical, LLC announced that it has entered into a license agreement with Wright Medical Technology, Inc. (NASDAQ:WMGI) relating to KFx patents used in knotless double row rotator cuff repair.

Under the agreement, Wright and its affiliates will have the right to promote the use of products and techniques for knotless double row rotator cuff repair as claimed in US Patent number 7,585,311 and related patents and applications for the life of those patents. In addition, KFx and Wright agreed to dismiss the related pending litigation between the parties.

Arthrex, Inc. has paid in excess of $35m in damages and interest for its infringement of KFx’s Knotless Double Row Fixation method as described in KFx’s U.S. Patent No. 7,585,311.

Terms of the licensing agreement were not disclosed.

“We are proud to have our innovation recognized by Wright. Previously we announced our licensing agreements with Smith & Nephew, Inc. (NYSE:SNN), Mitek, a Johnson & Johnson Company (NYSE:JNJ), and ConMed (NASDAQ:CNMD) for the same patents. I am pleased with the licensing arrangement with these four world leaders and knowing KFx’s valuable double row knotless rotator cuff technology will reach even more patients,” indicated Tate Scott, President and Chief Executive Officer.

About KFx Medical, LLC

KFx Medical LLC was founded in 2003 to develop products for tissue fixation in a variety of orthopedic surgical procedures performed on the shoulder, knee, foot, and ankle. KFx provides simple systems for orthopedic surgeons focused on sports medicine. The company is privately held. Investors include Alloy VenturesCharter Life SciencesArboretum VenturesMontreux Equity Partners, and MB Venture Partners.


KFx Medical, LLC
Tate Scott
President and Chief Executive Officer

Smith & Nephew Supports AAFAO Courses with Donation of More Than $3M of Equipment to The Podiatry Institute

LONDONMarch 19, 2018 /PRNewswire/ — Smith & Nephew (NYSE: SNN; LSE:SN), the global medical technology business, today announces the donation of more than $3M of trauma plates and screws, external fixation implants and instruments to The Podiatry Institute (PI). This equipment will be used to support ongoing educational courses conducted at the PI through the American Academy of Foot and Ankle Osteosynthesis (AAFAO).

Smith & Nephew has been the sole sponsor of the comprehensive and advanced educational courses conducted by the PI and AAFAO for the past four years, contributing to resident education for nearly 1600 participants. The company not only provided the surgical equipment and personnel support for these courses, but also hosted the event at its world class Innovation Center in Memphis, Tenn.

“Smith & Nephew has always been proud to support this important training. We view this donation as an important business need for podiatric resident training and their future patients,” said John Clausen, Vice President Global Marketing, Trauma and Extremities. “Along with this donation of surgical equipment, we will also continue to provide support with the appropriate Smith & Nephew personnel.”

The AAFAO was founded in 2014 for the sole purpose of training podiatric residents in the techniques and skills of skeletal fixation, trauma and reconstructive surgery of the foot and ankle. Courses are led by some of the best podiatrists in the profession with curriculum covering application of the principles and techniques for current and novel approaches to reconstructive surgery on the foot and ankle. This donation allows the AAFAO and PI to host these courses multiple times a year while opening up opportunities for multiple sponsors.

About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound ManagementSports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2017 were almost $4.billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.comfollow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward- looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

™ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.

SOURCE Smith & Nephew

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Trice Medical Achieves CE Mark and Health Canada Approval for Mi-Eye 2™, Performs First Cases in Toronto and the UK

U.S. based, Trice Medical, announced today the completion of its first successful case performed in the United Kingdom, after receiving CE (Conformité Européenne) Mark of approval in Europe for the mi-eye 2™, as well as entry into Health Canada.

Today’s case was performed by Mr. Tony Andrade, a Consultant Orthopaedic Surgeon at Circle Reading Hospital. “This is a fantastic opportunity to be able to show patients what’s going on inside their joints and talk them through it live as you see the pathology. This is something that’s been needed for a long time to aid patient’s understanding of their condition. It’s useful not just for diagnostic purposes, but it allows for the delivery of injections into the appropriate targeted area.” said Mr. Andrade.

The early success of Trice Medical’s mi-eye 2, which was launched in the U.S. in 2017, has captured the attention of medical professionals who are embracing the technology as a new diagnostic modality. After the first year of commercial launch, the mi-eye is currently being used by over 200 institutions across the states. The disposable needle embedded with a wide-angle camera lens enables physicians to diagnose joint injuries right in their clinic, and provide their patients with immediate answers to the cause of their pain.

“Truly disruptive technology always provides value by enhancing care and lowering cost. This approach to diagnosis is such a proposition.” Stated Jon J.P. Warner, MD. Chief, MGH Shoulder Service and Professor of Orthopaedic Surgery at Harvard Medical School, regarding the mi-eye 2 technology.

“Trice is proud and excited to be commercializing the mi-eye 2 into Europe and Canada. MRI and Ultrasound will always be good options for patients with sports injuries. We are thrilled to add disposable in-clinic arthroscopy to the list of available tools physicians have to be able to assess joint injuries. In many countries, the mi-eye 2 has a chance to save weeks to months of the treatment pathway to surgery AND provide a dynamic image of the joint. The is truly an example of innovation in the new world of value-based medicine,” said Mark Foster, Chief Commercialization Officer and VP of Worldwide Sales at Trice Medical.

Additionally, Dr. Anthony Miniaci of the Cleveland Clinic Canada has completed the first cases performed by a surgeon in Toronto, ON. The advent of this technology in the Canadian market has the potential to provide patients with a dramatic amount of time saved in their overall continuum of care per injury.

Today’s patient had this to say about her experience, “I had an operation back in December but was still having some knee problems. I didn’t want to go through another general anesthetic operation so Mr. Andrade recommended the mi-eye procedure would be a good option…The experience overall was fantastic, and I didn’t feel any pulling, tugging or pressure. Mr. Andrade has now identified what we need to do next for my treatment. I would definitely recommend it to others.”

About the mi-eye 2™:

Trice Medical’s mi-eye 2, is a handheld, single-use, and disposable direct visualization tool. The mi-eye 2 was specifically designed for use in the clinic setting, consisting of a single stick percutaneous, and self-blunting design which deploys an integrated camera and a light source. The procedure is performed with local anesthetic and provides patients with an alternative to traditional diagnostic modalities, such as time-consuming and often inaccurate MRIs. The mi-eye is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. mi-eye 2 is available for prescription use only.

About Trice Medical:

Trice Medical was founded to fundamentally improve orthopedic diagnostics for the patient, and the physician providing instant answers. Trice Medical has pioneered fully integrated camera-enabled technology, the mi-eye 2, that provides a clinical solution optimized for the physician’s office. Trice Medical’s mission is to provide more immediate and definitive patient care, eliminating the false reads associated with current indirect modalities and significantly reduce the overall cost to the healthcare system.

Contact Trice Medical:

+1 (610) 989-8080


Source: Trice Medical

Histogenics Corporation Announces Financial and Operating Results for the Fourth Quarter and Year Ended December 31, 2017

WALTHAM, Mass., March 15, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operational results for the quarter and year ended December 31, 2017.

“We achieved multiple, significant milestones in our global development strategy for NeoCart in 2017, providing a strong foundation for additional value creation in 2018. With the completion of enrollment in the NeoCart Phase 3 clinical trial in the first half of 2017, we are on track to report top-line data from this trial and potentially submit a Biologics License Application for this novel restorative cell therapy in the third quarter of 2018. In parallel we are initiating pre-commercialization activities for the U.S. market in advance of a potential launch of NeoCart in fourth quarter of 2019, and we continue to hear positive anecdotal feedback from our investigators regarding NeoCart patients,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We also made significant progress on the international expansion of the NeoCart platform by completing formal discussions with the Japan Pharmaceuticals and Medical Devices Agency on the development and regulatory pathway for NeoCart in Japan.  Our robust historical data packages and the PMDA conclusions were instrumental in our ability to complete the licensing agreement with MEDINET for the rights to develop and commercialize NeoCart in Japan.”

2017 and Recent Milestones

NeoCart Clinical, Regulatory and Commercialization

  • Completed enrollment for NeoCart Phase 3 clinical trial: In June 2017, Histogenics enrolled the final patient for its 249-patient Phase 3 randomized, controlled clinical trial conducted against the current standard of care, microfracture. The trial is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration (the FDA).
  • Executed licensing agreement for the development and commercialization of NeoCart in Japan with MEDINET Co., Ltd. (MEDINET): In December 2017, Histogenics entered into an agreement with MEDINET, a pioneering leader in the development and commercialization of cancer immuno-cell therapy technologies, for the development and commercialization of NeoCart for the Japanese market.  The agreement included a $10 million up-front payment, potential total payments of up to $87 million in total milestones and tiered royalties on sales. MEDINET intends to initiate NeoCart clinical development in Japan in the second half of 2018, and may enter the Japanese market in 2021, if approved.
  • Completed formal discussions with the Japan Pharmaceuticals and Medical Devices Agency (PMDA) to establish the development/regulatory pathway for NeoCart in Japan: Histogenics successfully concluded formal discussions with the PMDA in the second quarter of 2017. Feedback from the PMDA was positive and included the determination that a 30-patient, one-year confirmatory clinical trial with Japanese patients, comparing NeoCart to microfracture, would be sufficient for applying for full Marketing and Manufacturing Authorization in Japan in conjunction with data from Histogenics’ fully enrolled U.S. Phase 3 clinical trial. Additionally, the PMDA agreed that NeoCart would be regulated as a Regenerative Medicine Product, as covered by the recently enacted laws in Japan, and that Histogenics may supply the confirmatory clinical trial from the U.S. using the current good manufacturing processes (cGMP) for NeoCart.
  • Confirmed significant unmet need in cartilage repair through U.S. and Japan NeoCart market research: Histogenics conducted primary market research in the U.S. and Japan with approximately 200 orthopedic and sports medicine surgeons across both markets. The findings provide support for Histogenics’ assumptions regarding the size of each market, the lack of satisfactory solutions, and confirm the need for a novel cartilage repair therapy. Surgeons noted a strong desire for a safe and effective alternative to microfracture that may potentially offer patients a more rapid recovery from pain and return to function as well as a durable treatment response.

NeoCart Data Publications and Presentations

  • Generated additional peer-reviewed data that may support the upcoming NeoCart regulatory submissions and highlight the potential of Histogenics’ RCT platform: The published results included analyses of the compressive properties of engineered cartilage tissue grown with chondrocytes seeded in a porous scaffold in a study titled “In Vitro Culture Increases Mechanical Stability of Human Tissue Engineered Cartilage Constructs by Prevention of Microscale Scaffold Buckling,” which appeared in the peer-reviewed Journal of Biomechanics. In addition, a study appearing in the Journal of Orthopaedic Research entitled “Mechanical Properties and Structure-Function Relationships of Human Chondrocyte-Seeded Cartilage Constructs After In Vitro Culture” evaluated 3-D bioprinting of collagen and chondrocytes. These studies may support both process optimization and a potential Biologics License Application (BLA) filing for NeoCart, as well as the future development of additional product candidates based on the RCT technology platform.
  • Podium and poster presentations at Orthopedic Research Society (ORS) Annual Meeting:  Dr. Shuichi Mizuno, Ph.D., a scientific founder of NeoCart, Assistant Professor, Orthopedic Surgery, Brigham and Women’s Hospital (BWH), and Harvard Medical School, delivered a podium presentation on NeoCart and Histogenics’ RCT technology platform at the ORS Annual Meeting on March 10, 2018.  In addition, three additional poster presentations on NeoCart were presented during the meeting.  Data presented on these posters are available here.


  • Enhanced executive team ahead of potential approval and commercialization of NeoCart:In October 2017, Histogenics promoted Stephen Kennedy from Chief Technology Officer to Executive Vice President & Chief Operating Officer. In June 2017, Donald Haut was appointed Chief Business Officer. Both individuals possess strong professional experience that will be instrumental as Histogenics prepares for potential NeoCart commercial manufacturing and launch.
  • Completed registered direct financing: In January 2018, Histogenics raised net proceeds of $5.9 million dollars from a registered direct offering of its common stock. The proceeds from the offering provided an important source of additional funding and flexibility in advance of a potential NeoCart BLA filing.

2018 Corporate Objectives

  • Report NeoCart top-line Phase 3 data and submit BLA: Assuming positive results from the report of top-line superiority data from the NeoCart Phase 3 clinical trial in the third quarter of 2018, Histogenics remains positioned to submit a BLA with the FDA thereafter in the third quarter of 2018.
  • Continue advancement of NeoCart U.S. commercialization strategy: In advance of potential FDA approval of NeoCart, Histogenics intends to continue to prepare for a potential NeoCart launch in the U.S., including the assembly of a leading Clinical Advisory Board, the further development of marketing and reimbursement strategies and the initial development of sales and medical science liaison territories.
  • Leverage collaborations to generate and publish additional data to support BLA and foreign regulatory filings and potential U.S. commercialization of NeoCart: Histogenics expects to continue to generate data from its collaborations with BWH, Cornell University (Cornell) and Intrexon Corporation (Intrexon).  Anticipated presentations and publications in 2018 include additional biomechanical and three-dimensional printing data from the collaboration with Cornell, the use of chondrocytes to develop new products to treat additional soft-tissue and musculoskeletal-related disorders from the collaboration with BWH and proof-of-concept data from studies combining Intrexon’s induced Pluripotent Stem Cell (iPSC) technology and Histogenics’ NeoCart platform to manufacture next generation, NeoCart restorative cell therapies using iPSC-derived chondrocytes.
  • Secure additional manufacturing capacity: Subject to positive top-line data from the NeoCart Phase 3 clinical trial, Histogenics intends to initiate the design and buildout of additional space to support expected increased commercial manufacturing requirements in future years following the initial launch of NeoCart.
  • Support MEDINETS’ Japan clinical trial and regulatory activities: Histogenics is working closely with MEDINET on the development of NeoCart for the Japanese market. Specifically, the companies intend to work on the preparation of a clinical trial notification to support the planned NeoCart Phase 3 clinical trial in Japan in the second half of 2018. In addition, Histogenics intends to continue to explore additional licensing opportunities for NeoCart outside of North America.

Financial Results for the Year Ended December 31, 2017

Histogenics’ loss from operations was $(25.0) million for the year ended December 31, 2017, compared to $(30.3) million for the year ended December 31, 2016. The decrease in operating loss was driven by a reduction in research and development expenses and partially offset by an increase in general and administrative expenses.

Research and development expenses were $15.6 million for the year ended December 31, 2017, compared to $21.6 million for the year ended December 31, 2016. The decrease was primarily due to decreases in collaboration, consulting and temporary labor expenses, clinical trial-related costs, personnel-related expenses and repairs and maintenance costs concurrent with the wind up of enrollment in our NeoCart Phase 3 clinical trial. General and administrative expenses were $9.4 million for the year ended December 31, 2017, compared to $8.5 million for the year ended December 31, 2016. The increase was primarily due to increased activities related to potential commercialization of NeoCart and was driven by increases in personnel-related costs, professional fees and facility-related and stock-based compensation expenses.

Basic net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(13.9) million, or $(0.97) per share, for the year ended December 31, 2016. The increase in basic net loss attributable to common stockholders is attributable to the conversion into common stock in 2017 of a significant portion of the convertible preferred stock issued in connection with the 2016 private placement and changes in the fair value of the warrants issued in connection with the 2016 private placement, both of which were offset by a reduction in operating expenses in 2017 relative to 2016. Diluted net loss attributable to common stockholders was $(22.5) million for the year ended December 31, 2017, or $(0.99) per share, compared to $(31.4) million, or $(2.18) per share, for the year ended December 31, 2016. The difference in diluted net loss per share is primarily due to a reduction in operating expenses.

At December 31, 2017, Histogenics had cash, cash equivalents and marketable securities of $8.0 million, compared to $31.9 million at December 31, 2016. Cash at December 31, 2017 excludes approximately $9.0 million net of expenses received in January 2018 in connection with the licensing agreement entered into with MEDINET in December 2017 and $5.9 in net proceeds from the registered direct offering completed in January 2018.

Histogenics expects total operating expenses of between $29 million and $31 million for the year ending December 31, 2018 and believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, March 15, 2018 at 8:30 a.m. EDT.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID “7394538” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the SEC and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018.  In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

(in thousands, except share and per share data)

Three Months Ended
December 31,
Year Ended
December 31,
2017 2016 2017 2016
Revenue $   ‒ $   ‒ $   ‒ $   ‒
Operating expenses:
Research and development   3,366   5,317   15,566   21,577
General and administrative   2,667   2,389    9,384    8,530
Impairment of intangible asset    ‒    200    –    200
Total operating expenses   6,033   7,906   24,950   30,307
Loss from operations   (6,033 )   (7,906 )   (24,950 )   (30,307 )
Other income (expense):
Interest income (expense), net   20   (5 )    134    (60 )
Other income (expense), net    25    50    (116 )    (248 )
Warrant expense   –    (44 )   –    (3,100 )
Change in fair value of warrant liability    (808 )   16,968    (1,482 )   17,507
Total other income (expense), net    (763 )   16,969    (1,464 )   14,099
Net Income (loss) $   (6,796 ) $   9,063 $    (26,414 ) $   (16,208 )
Net Income (loss) attributable to common stockholders
Basic: $   (6,129 ) $   5,844 $    (22,499 ) $    (13,863 )
Diluted: $    (6,129 ) $    (11,125 ) $    (22,499 ) $    (31,370 )
Net Income (loss) per common share:
Basic: $   (0.26 ) $    0.34 $   (0.99 ) $   (0.97 )
Diluted: $   (0.26 ) $    (0.63 ) $   (0.99 ) $   (2.18 )
Weighted-average shares used to compute earnings (loss) per common share:
Basic:   24,005,598   17,143,121   22,669,819   14,256,954
Diluted:   24,005,598   17,508,120   22,669,819   14,389,192

(in thousands, except share and per share data)

  December 31,   December 31,
  2017   2016
Cash, cash equivalents and marketable securities $     7,981 $   31,908
Prepaid expenses and other current assets     194     173
Property and equipment, net   2,723   3,860
Other assets, net     137     137
  Total assets $   11,035 $   36,078
Current liabilities $     3,805 $     5,171
Warrant and other non-current liabilities   18,498   17,340
Total stockholders’ equity (deficit)   (11,268 )   13,567
  Total liabilities and stockholders’ equity (deficit) $   11,035 $   36,078


Green Sun Medical Wins SXSW Pediatric Device Competition Held in Austin, Texas

Fort Collins, CO, March 14, 2018 (GLOBE NEWSWIRE) — On March 13, 2018, medical device company Green Sun Medical won first place at the South by Southwest (SXSW) Impact Pediatric Health Pitch Competition in Austin, Texas.

Green Sun Medical is developing a dynamic scoliosis brace that applies continuous corrective pressure to the spine and allows physicians to monitor remotely the performance of the brace. Current treatments for scoliosis include spinal fusion surgeries, and braces developed over 40 years ago.  The company has raised over $2.5 million in equity and awards.

The competition was part of the annual conference to foster innovation that will advance pediatric healthcare and address the unmet surgical and medical device needs for children. The Impact Pediatric Health competition judges were from eight leading children’s hospitals including Boston, LA, Seattle, Atlanta, Cincinnati, Stanford, Philadelphia and Texas.

During the competition, ten finalists had three minutes to present their proposal to the judging panel, followed by a seven-minute question and answer session. This competition was created to foster innovation in the pediatric device sector.  The pediatric device sector continues to lag behind adult device development and creates a host of challenges for doctors when treating children.

“We are honored to have our dynamic scoliosis brace recognized by executives from these leading children’s hospitals,” said Jamie Haggard, CEO of Green Sun Medical. “These hospitals have opened up expansion potential after we complete a pilot study with the dynamic scoliosis brace.” The study will begin this spring at the National Scoliosis Center.

The award has culminated an impressive 18 month run of winning awards including the 2017 pediatric device competition sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), an FDA-funded consortium led by Children’s National Health System.  In October of 2016, 3000 medtech executives selected Green Sun Medical as the grand champion for best innovation at the Medtech Innovator Competition.  The company was also awarded a two-year grant to establish a residence at the Johnson & Johnson JLABS in South San Francisco.

Green Sun Medical is a graduate client company of Innosphere, Colorado’s leading technology incubator accelerating the success of high-impact science, engineering and technology startup and scaleup companies.

Green Sun Medical also completed its $2M Series-A round for development of its dynamic scoliosis brace with a $500k investment from the AngelMD Catalyst Fund.

To learn more about Green Sun Medical visit http://www.greensunmedical.com

About Green Sun Medical:
Green Sun Medical has a team of the world’s finest scoliosis thought leaders dedicated to transforming the treatment of Adolescent Idiopathic Scoliosis. They are developing a comfortable, dynamic brace that applies continuous corrective pressure and allows the physicians to track the performance of the brace in real time. www.greensunmedical.com


A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/c4adfe43-32b5-4250-b08f-c5e7eedef213

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/59f15107-774b-4546-89bc-45e92fb36d4d

Jamie Haggard
Green Sun Medical