Medtronic sells monitoring, recovery products business for $6.1 billion

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Implanet Announces Q1 2017 Revenue

April 18, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (OTCQX:IMPZY) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces its revenue for the first quarter of 2017.

In € thousands – IFRS* Q1 2017 Q1 2016 Change
Spine (JAZZ) 1,066 837 +27%
Knee + Arthroscopy 982 1,151 -15%
Total revenue 2,048 1,988 +3%

*Unaudited data

In Q1 2017, Implanet recorded a +3% increase in revenue to €2,048 thousand (versus €1,988 thousand in Q1 2016). Jazz® activity increased by +27% to €1,066 thousand (vs. €837 thousand) and accounted for 52% of total revenue (vs. 42%), offsetting the 15% decrease in Knee sales to €982 thousand (vs. €1,151 thousand) because of difficulties in Brazil.

In France, the United States and the rest of the world, Jazz® sales grew by +61% to €417 thousand, +3% to €415 thousand and +34% to €234 thousand respectively. In markets where the Company operates directly, the high-potential degenerative bone disorder segment (adult treatment) saw sales increase by +60% to €353 thousand, accounting for 42% of Jazz® sales (vs. 36% in Q1 2016). Implanet sold 2,032 Jazz® implants over the quarter (vs. 1,197), a 70% volume growth.

Ludovic Lastennet, CEO of Implanet, says:

Our overall quarterly growth, whilst penalized by the decrease in Knee exports, shows a continuous improvement in Jazz® in terms of both its adoption by surgeons and its share of the Company’s product mix. We have laid the foundation of our current growth by intensifying our efforts regarding the recognition of the clinical value of JAZZ® and the comprehensive nature of our product range. Lastly, we have treated almost 4,000 patients and with more than 20,000 Jazz® implants since its launch. For 2017, we remain confident in our ability to sustain continued growth in Jazz® revenue and establish it as a benchmark in spine surgery. Regarding the Knee segment, we expect activity to stabilize during the second quarter of 2017.

Next financial press release: Q2 2017 revenue, on July 18, 2017

Annual general meeting: the combined general meeting of Implanet will be held on May 5, 2017 at 10:00 AM CET at the Company headquarters: Technopole Bordeaux Montesquieu, Allée François Magendie, 33650 Martillac, France.
You are invited to participate in the voting of the resolutions. For further information, please send your contact details to: implanet@newcap.eu

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

Disclaimer
This press release contains forward-looking statements concerning Implanet and its activities. Such forward looking statements are based on assumptions that Implanet considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Implanet registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on April 26, 2016 under number R.16-035 and available on the Company’s website (www.implanet-invest.com), and to the development of economic situation, financial markets, and the markets in which Implanet operates. The forward-looking statements contained in this release are also subject to risks unknown to Implanet or that Implanet does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Implanet that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements.

This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for Implanet shares in any country.

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Vexim: New Product Launch MASTERFLOW™ PLUS, a new product targeted at low energy osteoporotic fractures

April 18, 2017

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

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces the launch in Germany of its new product Masterflow™ Plus, a new product targeted at low energy osteoporotic fractures.

“With this new product developed specifically for the German market, we aim to further increase our penetration and growth in that region. Dedicated to low energy osteoporotic fractures, a high-volume yet lower-price market, Masterflow™ Plus is designed to be competitive in that area and to offer hospitals and physicians a valid alternative to treat osteoporotic compression fractures. Meanwhile, the SpineJack® will continue its penetration of the German market especially on high-energy and complex vertebral fractures where vertebral body restoration and spinal balance correction need to be applied. This investment demonstrates VEXIM’s objective of becoming a significant Spine Trauma leader in Germany providing hospitals, surgeons and patients with best treatment options“, said Vincent Gardès, CEO of VEXIM.

Masterflow™ Plus, a new product dedicated to Germany

Masterflow™ Plus is a new solution designed to treat Vertebral Compression Fractures (A1-type according to Magerl and AOSpine Classifications) in Osteoporotic Bone. Masterflow™ Plus allows a Controlled Cement Augmentation Procedure first through vertebral body height elevation, and second by stabilizing the fracture using Cohesion® Bone Cement injection. This new system also offers the opportunity to treat multiple vertebral levels in a single surgery when combined with the Masterflow™ Injection System. The injector Masterflow™, launched in 2015, is a sophisticated solution providing a controlled high viscosity cement injection, at a safe distance1from the radiation field for multi-level procedures2.

This new method using the Jack Device3 and Masterflow™ injector offers the possibility to restore fractured vertebrae sustainably and inject high viscosity cement safely into the vertebrae. The Jack Device will be removed and used again for a possible next level. The advantage is a controlled cavity creation and directed height restoration where it is needed. The surgeon can control the expansion of the device.

MasterflowTM Plus is a competitive price solution for multi-level fracture treatments, based on the similar and patented concept of SpineJack®, yet functioning in unidirectional form and with less force-capabilities in its height restoration. The instrument is single-use and disposable and delivered in combination with a solid injection system that is capable of delivering high viscosity cement under complete control of flow to accommodate the surgeons in the operating room.

With the commercialization of the MasterflowTM Plus in Germany, the biggest market in Europe (worth €70 million), we also gained access to Clinicpartners, Agaplesion, AGKAMed and Paul Gerhard Diakonie, counting for 250+ clinics for Vexim to sell into.

Financial reporting schedule:
2nd quarter sales: July 11th, 20174

About VEXIM, the innovative back microsurgery specialist
Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital5, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®6, an innovative implant for treating Vertebral Compression Fractures
The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 Mehlman, Charles T., DiPasquale, Thomas G. Journal of Orthopaedic Trauma: August 1997 – Volume 11 – Issue 6 – pp 392-398 Radiation Exposure to the Orthopaedic Surgical Team During Fluoroscopy: “How Far Away Is Far Enough?”
2 http://en.vexim.com/professionals/injection-system-masterflow/
3 The “Jack Device” is a Vertect product used under an exclusive distribution agreement by Vexim
4 Indicative date, subject to changes.
5 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
6 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
Tel.: +33 5 61 48 48 38
investisseur@vexim.com
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94
vexim@alizerp.com

CMIS becomes 1st ASC in IL to add Robotics for Uni & Total Joint Reconstructive Surgery Procedures

Just over a year ago Surgical Care Affiliates, Inc. (“SCA”) partnered with the physician members of The Center for Minimally Invasive Surgery (“CMIS”) in Mokena, IL. The Partnership operates an ambulatory surgical facility that represents an important access point for high quality, low cost surgical services in Mokena and the surrounding region.

In April 2017 CMIS made yet another investment for our surgeon partners to provide superior clinical care at affordable costs as compared to typical hospital fees. CMIS is a unique ASC as it features the following to its surgeon partners and their patients:

  • 13 years of Total Joint & Complex Spine experience
  • AAAHC Accredited
  • Contracted with major commercial payors for high-acuity spine and total joint replacement
  • Unique Recovery Care Center allows for patients to stay overnight with nursing care for up to 48 hours or with Medical Director Review an additional 24hr may be implemented (typical length of stay is 1 night). Patients are treated to spacious private rooms and catered meals.
  • Advanced technology for spine including high power microscopes, Cell Saver capability, Neuromonitoring and O-arm Surgical Imaging System
  • Recent investment in updated Orthopedic equipment including Arthrex Synergy arthroscopy systems, Stryker Power (new overhead lights & towers not shown in image)
  • Anesthesiology group has served at center for over 10 years

 

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Blue Cross and Blue Shield of Minnesota Announces New “Future Of Health Care” Initiative

EAGAN, Minn., April 17, 2017 /PRNewswire-USNewswire/ — Blue Cross and Blue Shield of Minnesota (Blue Cross) announced a new strategic “Future of Health Care” initiative today aimed at addressing health care cost challenges in Minnesota and beyond.  With three strategic pillars, the initiative looks to spur innovation and engagement around new approaches to help build a more stable and sustainable health care market for Blue Cross members and Minnesotans statewide.

“Health care is at a crossroads,” said Michael Guyette, president and CEO of Blue Cross and Blue Shield of Minnesota, announcing the new initiative. “Costs continue to rise, and the premium dollars coming in just aren’t covering the dollars going out in payments to hospitals, physicians, and drug companies.  Our members are stretched.  Our employer partners are stretched.  We need new ideas and approaches that can help members, employers and providers move forward together.

“Blue Cross is the leading health plan in Minnesota.  We can’t wait for someone else to step up.  We need to lead – and that’s what our Future of Health Care initiative is about.  We’re going to innovate to make the health care market more stable and sustainable for everyone, and this is how we are moving forward.”

Earlier this month, Blue Cross reported rising health care costs had pushed the state’s largest health care plan to record operating losses in 2016.  With a negative operating margin, the state’s largest non-profit health plan said it had been necessary to dip deeply into reserves to cover costs, despite 2016 premium increases in most segments.

In Minnesota’s individual market segment, Blue Cross said it had absorbed unsustainably large losses, in addition to major cost pressures in public programs and heavy utilization by Minnesotans covered under the state’s Medicaid program.

The losses reported by Blue Cross were not unique.  Most of Minnesota’s health plans reported dismal 2016 financial performance.  Medicaid losses are a particular problem, with costs reaching critical levels.  There’s already been significant disruption and instability for Medicaid program enrollees.

Minnesota health care costs are a flashing red light,” Guyette said.  “It’s not sustainable.”

“We need to innovate,” he said.  “Blue Cross has served Minnesotans for more than 80 years. We have nearly 3 million members looking to us for leadership.”

The Future of Health Care initiative has three strategic pillars – Clinical Innovation, Care Management, and Network and Payment – with specific initiatives under each:

  • The Clinical Innovation pillar will help members better navigate the care system and address their specific health care needs in the best way possible through collaborative partnerships.
    For example, the Mayo Clinic Living Donor Kidney Program leverages Mayo’s expertise and innovative treatment for complex medical conditions.  Blue Cross worked with Mayo Clinic to create a new program, launched recently by a handful of Minnesota employers, to match potential donors willing to help someone by donating a kidney, but who may not be compatible with that relative or friend.  The program creates a “donor chain,” matching people to donate a kidney to someone they didn’t know, while someone else donates an organ to their friend or relative. Already, a “paired donation” type program is being used in 20 percent of Mayo’s kidney transplant cases.  The result is better clinical outcomes and lower costs for Blue Cross members.  Blue Cross is also starting to guide members in need of specific orthopedic procedures and those who have low back pain to high value providers.
    Other new initiatives include a new consumer-centric diabetes solution, designed in collaboration with the American Diabetes Association that features new digital tools, peer support, care coordination and value-based incentives.  A new Maternity Management pilot for Blue Cross Medicaid members features early member engagement and enhanced support for new mothers-to-be.  The pilot is community-based and leverages community and provider partners, including county-based public agencies, to better support women and their babies at this most important time.
  • Advancing Care Management, Blue Cross says it will leverage a broad range of tools to help its members’ receive better coordinated and evidence-based care, everything from basic health coaching and utilization management to care advocacy, specialty-care coordination and care transition support.  The company said it will continue its emphasis on high-complexity care, leveraging dedicated managers and health coaches, while also creating a new “inter-disciplinary care rounds” approach, in which cross-functional clinical teams identify holistic approaches on behalf of members.
  • In the Network and Payment pillar, the plan will focus on identifying and leveraging high value networks considering provider cost, efficiency and quality, both statewide and regionally.  Building on advances and innovations in this area, Blue Cross is already working to incorporate aligned incentive contracts, patient-centered medical homes, bundled payments for key procedures, value-based contracts for Medicaid member providers, and new insurance programs leveraging Accountable Care Organizations (physicians, clinics and hospitals) capable of delivering high-value care to members.
    Through payment reform, Blue Cross wants to lower the cost of care and achieve better predictability in employer and member out-of-pocket costs by establishing a care model where it pays for value, not volume, shifting to a system that rewards quality and affordability.
    The results of an effective care system that prioritizes value are fewer inpatient hospitalizations, lower readmission rates, higher quality care, and more appropriate use of services when compared to volume-based care.

“We’re already innovating to advance our Future of Health Care pillars,” said Guyette, “but we’re also going to partner with our providers, employers and members on new ideas and new approaches.  We’ll need everyone working together if these cost challenges are to be met.”

About Blue Cross and Blue Shield of Minnesota
Blue Cross and Blue Shield of Minnesota, with headquarters in the St. Paul suburb of Eagan, was chartered in 1933 as Minnesota’s first health plan and continues to carry out its charter mission today: to promote a wider, more economical and timely availability of health services for the people of Minnesota. A nonprofit, taxable organization, Blue Cross is the largest health plan based in Minnesota, covering 2.9 million members in Minnesota and nationally through its health plans or plans administered by its affiliated companies. Blue Cross and Blue Shield of Minnesota is an independent licensee of the Blue Cross and Blue Shield Association, headquartered in Chicago. Go to bluecrossmn.com to learn more.

 

SOURCE Blue Cross and Blue Shield of Minnesota

Related Links

http://www.bluecrossmn.com

Rational Surgical Solutions to Exhibit at 2017 AAOE Annual Conference

DES MOINES, Iowa, April 17, 2017 /PRNewswire/ — Rational Surgical Solutions (RSS) will exhibit at Booth #804 at the American Alliance of Orthopaedic Executives (AAOE) Annual Conference (April 22-25, Indianapolis). RSS will showcase two videos for its Rati-Fi® Patient Engagement & Informed Consent App, total hip replacement and Total Knee Replacement. The Rati-Fi® platform helps orthopaedic practices see more patients, streamline and automate procedures, and meet MIPS criteria. The AAOE Annual Conference brings together more than 500 orthopaedic practice executives and their staff from around the country for four days of education, networking, and professional development.

“The aging baby boomer population has increased the demand for hip replacement and knee replacement surgeries. Total knee replacements will increase 673% by 2030, with total hip replacement operations growing 174% over the same period,” said Dr. Jonathan Fialkov, RSS President & Founder. “This growth, coupled with a diminishing surgeon workforce and the demands for meeting bundled care initiatives, puts practices under enormous pressure to increase patient flow and comply with the criteria needed for reimbursements.”

Fialkov explained that the Rati-Fi® Patient Engagement Platform can help practices on several levels. “Educating and engaging patients about their treatment options and follow up care significantly reduces the incidence of readmissions and improves patient outcomes. Our platform includes videos from MedSelfEd’s PreOp® and PostCare™ Centers that use medical illustrations, animations and plain language to describe medical procedures.” The application records the patient-physician consult, which patients and caregivers can review using a patient portal.

The Rati-Fi Application also improves practice efficiencies by automating routine procedures. “Practices can use the Rati-Fi System for secure patient-doctor messaging, and to text patients reminders about scheduling tests and upcoming appointments. The result is fewer patient complaints, fewer cancelled procedures, and fewer no shows,” said Fialkov.

About Rational Surgical Solutions
Rational Surgical Solutions, based in Des Moines, IA, was founded by Dr. Jonathan Fialkov, a urologist, in 2014. Dr. Fialkov’s extensive experience in his field and the healthcare industry, gives him unique insights into the challenges faced by physicians today. The company is developing a portfolio of products that will help physicians, surgeons and advanced practitioners leverage mHealth technology to improve patient care and education; revolutionize the informed consent process; increase the efficiency of healthcare providers; and reduce costs. For more information or to schedule a free demo visit: http://www.rati-fi.com.

SOURCE Rational Surgical Solutions

Related Links

http://www.rati-fi.com

Regenexx Network Using Regenerative Medicine Technologies in Interventional Orthopedics to Treat Pain

BROOMFIELD, Colo., April 17, 2017 /PRNewswire/ — “Interventional orthopedics in pain medicine practice” was recently published by Elsevier as a chapter in Techniques in Regional Anesthesia and Pain Management. The chapter, authored by Regenexx® founder Christopher J. Centeno, MD examines less invasive ways to treat orthopedic pain and injuries through autologous biologics, such as stem cells and platelet rich plasma (PRP), and the shift from surgical orthopedics to interventional orthopedics.

Interventional orthopedics utilizing advanced technologies, such as ultrasound and X-ray guidance, precise percutaneous injections of autologous biologics, and bone marrow concentrate, (BMC) expand nonsurgical options in the field of orthopedics. Citing the dramatic reduction in cardiac surgery rates since the adoption of the specialty interventional cardiology, the authors reveal, “We are poised on the brink of the same change in orthopedic care.” The authors also state, “The field of autologous biologics has the potential to alter the playing field of orthopedic care by allowing percutaneous injections to replace the need for more invasive orthopedic surgeries.”

The chapter covers three important tenets in the developing field that will allow Interventional Orthopedics to alter traditional orthopedic care in the future. First is the rapid expansion of injectates (material being injected), such as stem cells and PRP, that can help heal damaged tissue and that can effectively treat musculoskeletal tissues. Second is the precise image-guided placement of those injectates into those damaged tissues. And third is the development of new tools that will advance this regenerative-medicine technology. The chapter also highlights research that supports the use of bone marrow stem cells and the importance of education standards and organization, training, and retraining of physicians to meet these standards.

The full chapter “Interventional orthopedics in pain medicine practice” can be found online at http://www.sciencedirect.com/science/article/pii/S1084208X16300052.

Christopher J. Centeno, MD, is the CEO of Regenexx and an international expert and specialist in regenerative medicine and the clinical use of mesenchymal stem cells in orthopedics.  Dr. Centeno maintains an active research-based practice and has multiple publications listed in the US National Library of Medicine. He has also served as editor-in-chief of a medical research journal dedicated to traumatic injury and is one of the few physicians in the world with extensive experience in the culture expansion of and clinical use of adult stem cells to treat orthopedic injuries.

MEDIA CONTACT
Mark Testa
155014@email4pr.com
(303) 885-9630

SOURCE Regenexx

AMNIOX Obtains Federal Supply Schedule Contract for NEOX® and CLARIX® Product Lines

April 17, 2017

ATLANTA–(BUSINESS WIRE)–AMNIOX Medical, Inc., a TissueTech, Inc. company, announced a new Federal Supply Schedule contract for its NEOX and CLARIX product lines. The agreement provides the Military Health System broad access to NEOX Wound Allograft – indicated for use as a wound covering for dermal ulcers and defects – and CLARIX Regenerative Matrix – indicated for use as a surgical covering, wrap or barrier in orthopedic surgery and soft tissue repair.

The Military Health System encompasses the U.S. Department of Defense’s institutions providing health care to active duty and retired U.S. Military personnel and their dependents. This system provides healthcare coverage to 10.2 million lives. Amniox Medical is partnering exclusively with Alliant Healthcare, a verified Service-Disabled, and Veteran-Owned Small Business (SDVOSB). As an SDVOSB, Alliant is a priority provider of medical products and services to the Federal government with an extensive sales history with every VA and DoD hospital worldwide. Alliant provides customer support for the Amniox cryopreserved umbilical cord and amniotic tissue allografts to the Military Health System.

NEOX and CLARIX are available under codes FSS #V797D-50441 and DAPA #SP0200-05-H-0090.

“We are pleased to increase the availability of our unique technologies for the nation’s Veterans and Active Duty Military patients and the clinicians who deliver care to them,” said Tom Dugan, Chief Executive Officer of Amniox Medical. “Acknowledgement of the clinical benefits that our proprietary technology offers to patients continues to deepen among providers and payers, now including broad accessibility this very important patient population through this contract.”

Amniox Medical is the first provider of a human tissue allograft composed of both umbilical cord and amniotic membrane. The biological components of these tissues have demonstrated regenerative properties that can provide healing benefits to patients with numerous medical conditions. In utero, wound healing occurs rapidly and with minimal scar, and this restorative ability is innate to placental tissues, including umbilical cord and amniotic membrane. Heavy chain hyaluronic acid/pentraxin-3 is the key protein complex present in these tissues to orchestrate the healing process. Amniox utilizes its proprietary CryoTek™ process, a cryopreservation technology, to preserve the biological and structural integrity of the native tissue. Published studies have demonstrated that the CryoTek process more effectively preserves the structural and biological integrity of the tissue.

About Amniox Medical, Inc.

Founded in 2011 to serve the orthopedic and wound care markets, Amniox Medical is dedicated to developing and marketing regenerative therapies processed from umbilical cord and amniotic membrane utilizing its proprietary CryoTek technology. This process has been proven to preserve the innate biological and structural properties of the matrix, which can then be transplanted to adult wound and surgical environments. Amniox Medical procures its tissue through elective donation following healthy live birth via Cesarean section. Thorough donor screening is performed to ensure safety of its products. For additional information, please visit http://www.amnioxmedical.com

About TissueTech, Inc.

TissueTech, Inc., the parent company of Amniox Medical, Inc. and Bio-Tissue®, Inc., pioneered the development and clinical application of regenerative, amniotic tissue-based products. Amniox Medical develops and markets products for use in the musculoskeletal and wound care markets; Bio-Tissue develops and markets products for the ophthalmology and optometry markets. The National Institutes of Health (NIH) have supported TissueTech’s research with more than 30 continuous years of research grants. Since the company’s inception, clinicians have performed more than 250,000 human implants of the company’s products and published more than 300 peer-reviewed studies supporting its technology platform. The Company’s first product, AmnioGraft®, is the only tissue graft designated by the FDA as homologous for promoting ophthalmic wound healing while suppressing scarring and inflammation.

Contacts

for AMNIOX Medical, Inc.
Chris Gale
(646) 695-2883
cgale@greentarget.com

4WEB Medical Announces Record Growth in Q1 of 2017

BOCA RATON, Fla., April 13, 2017 /PRNewswire/ — 4WEB Medical, the industry leader in 3D printed implant technology, announced today at the annual meeting of the International Society for the Advancement of Spine Surgery (ISASS) that the company achieved its largest revenue quarter to date in the first quarter of 2017.  “The mark of a truly successful orthopedic implant company is sustained quarter over quarter growth, irrespective of market seasonality or other external factors,” said Geoffrey Bigos, Vice President of Spine Sales at 4WEB Medical. “Our continued success and rapid expansion is a testament to our surgeon customers belief in the difference that 4WEB’s Truss Implant Technology makes on surgical outcomes for their patients.”

4WEB’s record breaking quarter was highlighted by strong demand for its comprehensive Posterior Spine Truss System product line for TLIF procedures. The company also expanded sales and distribution into dozens of new hospitals during the quarter, making significant investments in sales infrastructure to further its reach into new markets. The first planned U.S. surgeries with the company’s new Lateral Spine Truss System in Q2 are certain to further advance its market leading position.

“The proliferation of 3D printed titanium implants across the industry has fueled the market adoption of these devices in spine surgery,” said Jim Bruty, 4WEB’s Senior Vice President of Sales and Marketing. “4WEB’s distinct advantages over competitive 3D printed and other titanium implants are clear; increased bone implant surface interface, more volume for bone through-growth, and transference of load throughout the implant to create a mechanical environment for biological fusion to occur.”

4WEB Medical is an implant device company founded in 2008 in Dallas, Texas. Thirty years of research in topological dimension theory led to the discovery of a novel geometry, the 4WEB, that can be used as a building block to create high-strength, lightweight web structures. The company leveraged this breakthrough along with cutting-edge 3D printing technology to develop 4WEB Medical’s proprietary truss implant platform. The 4WEB Medical product portfolio includes the Cervical Spine Truss System, the Anterior Spine Truss System, the Posterior Spine Truss System, the Lateral Spine Truss System, and the Osteotomy Truss System. 4WEB is actively developing truss implant designs for knee, hip, trauma and patient specific orthopedic procedures.

For more information about 4WEB Medical, 4WEB’s Truss Implant Technology, and the Spine Truss Systems, please visit www.4WEBMedical.com.

SOURCE 4WEB Medical

Related Links

http://www.4webmedical.com

Zyga Releases 24-month CT Fusion and Clinical Results for SImmetry SI Joint Fusion with Decortication

MINNETONKA, Minn., April 13, 2017 /PRNewswire/ — Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive devices to treat underserved conditions of the lumbar spine, today released 24-month CT Fusion and Clinical Results for its SImmetry Sacroiliac Joint Fusion System. This prospective, multi-site study evaluated long-term fusion and pain reduction in patients receiving SImmetry® Sacroiliac Joint Fusion.

The study evaluated 18 patients for radiographic evidence of fusion at 12 and 24 months following SI joint fusion with decortication and bone grafting. A systematic Computed Tomography (CT) review was predefined and performed by independent radiologists blinded to each other’s assessments. Fusion was defined as Solid (presence of solid continuous bridging bone across the treated joint), Possible (presence of possible continuous bridging bone across the treated joint), or No Fusion (no bridging bone). Previously-reported results demonstrated that 79 percent of patients had evidence of bridging bone at 12 months. At 24 months post-op 94 percent of patients had evidence of bridging bone, with 83 percent categorized as Solid fusion across the SI joint. Of patients with Solid fusion, 88 percent of the joints were fused within the area of decortication, demonstrating the importance of this step in achieving fusion.

In addition to fusion, the study demonstrated a 73 percent reduction in average pain at 24 months, maintaining the significant pain relief reported at earlier time points. There were no procedure- or device-related serious adverse events reported.

“Evidence is continually building to support sacroiliac (SI) joint fixation’s ability to effectively reduce pain in patients with SI joint disorders,” said Dr. William W. Cross III, an orthopedic surgeon specializing in pelvic disorders from Mayo Clinic in Rochester, MN who presented the data at the International Society for the Advancement of Spine Surgery (ISASS) 2017 Annual Meeting. “This study demonstrates the ability of the SImmetry system to achieve pain reduction comparable to other systems, while providing radiographically evident fusion as early as 12 months and increased fusion rates at 24 months. By supplementing fixation with decortication and bone grafting, I can be confident that my patients have the best possible foundation for biological fusion, and long-term relief.”

The Centers for Disease Control and Prevention lists back problems as the second most common cause of disability in U.S. adultsi. It has been reported that approximately 20 percent of all chronic low back pain derives from the sacroiliac jointii.

About Zyga Technology, Inc.

Zyga Technology, Inc. is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. In addition to marketing the SImmetry System, the company is conducting a U.S. multicenter clinical study of the Glyder Facet Restoration Device, an investigational, non-fusion, minimally invasive technology intended to provide relief from lumbar facet pain. The Company is exhibiting at the 2017 ISASS meeting in Boca Raton, Fla. until April 14. For more information, visit zyga.com.

i Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults—United States, 1999. JAMA. 2001; 285(12):1571-1572.
ii Cohen SP et al. Sacroiliac Joint Pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment. Expert Rev Neurother. 2013; 13(1):99-116

CONTACT:
Erin Morrison
Tel 952 698 9956
emorrison@zyga.com