ConforMIS Announces Sale of Over 50,000 Customized Knee Implants

BEDFORD, Mass., Oct. 04, 2016 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that develops, manufactures and sells joint replacement implants that are customized to fit each patient’s unique anatomy, today announced a significant milestone.  ConforMIS has sold more than 50,000 implants, each individually sized and shaped to fit each patient’s unique anatomy.  Unlike manufacturers of traditional “off-the-shelf” knee replacement implants that offer products with a limited range of sizes and geometries, ConforMIS offers a broad line of customized knee implants designed to restore the natural shape of a patient’s knee.  To commemorate this milestone, a group of male and female patients, ages 40-75, will be gathering in Boston to kick-off the ConforMIS Patient Ambassador Program.

“We are thrilled to be commemorating this important company milestone together with our deeply committed team of ConforMIS employees dedicated to delivering innovative, high quality technology.  We are in the business of helping surgeons and healthcare professionals treat their knee replacement patients by offering them a broad line of customized knee implants for individualized orthopedic care.  Understanding that patient-to-patient communication is one of the most meaningful experiences for potential patients seeking joint replacement options, we are excited to introduce a new program designed to facilitate and enable patient connectivity,” said Philipp Lang, MD, MBA, Chief Executive Officer and President of ConforMIS.  “With over 50,000 implants sold, we feel the timing is right to launch this initiative.  Our patients are unique, each and every one of them, and our Patient Ambassador Program will allow the everyday ConforMIS patient to share his or her story with others fighting a similar battle.”

This week ConforMIS is holding its first Patient Ambassador Summit, a special gathering of patients from across the United States treated with ConforMIS customized knee implants in one or both knees. This group includes some of the earliest patients to be treated with a ConforMIS knee implant alongside more recent patients.  The Patient Ambassador group is comprised of patients that have either a partial or total ConforMIS customized knee replacement ranging from the iUni, iTotal CR and iTotal PS, and each will share their personal story.  This week, these patients will have the opportunity to experience firsthand how ConforMIS solutions are individually designed and manufactured using its proprietary software and 3D printing technology.

Each ConforMIS partial and total knee implant, including iTotal® CR, iTotal® PS, iDuo® and iUni®, is developed using proprietary algorithms and computer software to map the articular surfaces of the knee joint, define the areas of disease and convert the imaging data into a three-dimensional model of the knee.  ConforMIS engineers then use computer-aided design, or CAD, software to design the customized implant and single-use, sterile surgical instrumentation that will precisely match the three dimensional model of the patient’s knee.

The focus on innovation in customized implants continues today at ConforMIS.  In March 2016 the company launched iTotal PS, which nearly triples the company’s addressable market.  Like iTotal CR, iTotal PS implants are customized for each patient to avoid compromises on implant fit, rotation and alignment, which can cause residual pain and functional limitations after surgery.

 About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In recent clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 500 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up athttp://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for ConforMIS, including statements about the Patient Ambassador Program, the potential clinical, economic or other impacts and advantages of using customized implants, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to results seen in ongoing and future clinical and economic studies of our products, risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our sales and other results of operations, the impact of patient communication programs, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent ConforMIS’s views as of the date hereof. ConforMIS anticipates that subsequent events and developments may cause ConforMIS’s views to change. However, while ConforMIS may elect to update these forward-looking statements at some point in the future, ConforMIS specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing ConforMIS’s views as of any date subsequent to the date hereof.

CONTACT:

Investor contact:

Oksana Bradley

ir@conformis.com

(781) 374-5598

 

Media contacts:

Bill Berry

Berry & Company Public Relations

Bberry@berrypr.com

(212) 253-8881

 

Lynn Granito

Berry & Company Public Relations

Lgranito@berrypr.com

(212) 253-8881

How 10 hospitals took their total joint replacement programs to the next level

Written by Laura Dyrda – September 29, 2016

The following 10 hospitals and health systems updated their total joint replacement programs with new initiatives such as data analytics, bundled payments, quality improvement and telehealth.

Here are their stories

Baptist Health System (San Antonio). Global professional services firm Navigant partnered with Baptist Health System in 2012 to develop and implement a program that would fit under the Center for Medicare and Medicaid Innovation’s Bundled Payments for Care Improvement initiative. The updates involved redesigning teams and improving the clinical information sharing strategy for better overall care. The program went live in October 2013 for joint replacements, including new initiatives for physician engagement; post-acute network partnerships; gainsharing and funds flow; and supporting analytics. A 2016 case study showed the hospital saved $2.3 million in the first year after participating in BPCI. The hospital also reported a 10 percent reduction in readmissions, 20 percent reduction in skilled nursing utilization and 22 percent reduction in patient rehab utilization.

Hoag Orthopedic Institute (Irvine, Calif.). Hoag Orthopedic Institute participated in the Cambridge, Mass.-based Institute for Healthcare Improvement’s Joint Replacement Learning Community in 2014 to gather data and identify areas to maximize value. In 2015, the hospital welcomed a chapter of Avant-garde, which provides hospitals with technology and analytics tools to measure clinical and cost data, to improve scalability and to set standards for care. The next step in the hospital’s journey to providing value-based care includes further data analytics for care cycles through the continuum of care. The hospital also was the subject of a Harvard Business School case study examining outcomes, cost reduction and reimbursement. Finally, the hospital has a bundled payment system covering services and participated in the Integrated Healthcare Association’s pilot program in 2010 and the National Orthopedic and Spine Alliance program in 2015.

Hospital for Special Surgery (New York City). The adult reconstruction and joint replacement service at Hospital for Special Surgery provides more than 9,000 hip and knee replacements per year and U.S. News & World Report has ranked the hospital as No. 1 in orthopedics for seven consecutive years. The hospital is using telehealth to engage patients before and after their surgeries to improve outcomes and stay connected to the patients after they return home. HSS and ViiMed developed a standardized framework telehealth program for personalized patient education, information and recorded video activities designed to open lines of communication between patients and providers. Among total knee replacement patients, 97 percent report pain relief and 96.3 percent report return to function two years after surgery.

 

 

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Preoperative Continuous Peripheral Nerve Blocks in Hip Fracture Patients

By Stuart Grant, MB, ChB, FRCA, Gavin Martin, MB, ChB, FRCA, and Ellen Flanagan, MD  –  Oct 5, 2016

  • Each year, at least 250,000 older people—those 65 years and older—are hospitalized for hip fractures.
  • More than 95% of hip fractures are caused by falling, usually by falling sideways.
  • Women experience three quarters of all hip fractures.
  • Women more often have osteoporosis.
  • Fall prevention programs are
    important.

When developing a plan to care for elderly patients with hip fractures, amassing a multidisciplinary team is the first step. With all stakeholders present charting the patient’s journey from arrival to discharge, a discussion of all areas of care and opportunities to reduce unwanted variability and improve care can take place.

As anesthesiologists working on the care improvement team, we had heard discussion about the severe pain many of these patients have to endure from arrival in the emergency room (ER) to continuation in other areas such as the X-ray suite, which we do not normally consider. As acute pain specialists with interests in regional anesthesia, we felt we could offer a better quality patient experience if we placed peripheral nerve catheters in these patients as soon as they arrived in the ER. In a previous review, Riddell et al[1] examined the use of femoral nerve blocks in the ER. Both single-shot and catheter techniques have shown benefit by reducing pain scores and opioid consumption. Additionally, reductions in respiratory and cardiac side effects have been noted without any increase in any adverse events.

In collaboration with ER colleagues, we developed a plan to call anesthesiology as soon as a hip fracture was diagnosed. We used an electronic order set, which is triggered by the ER provider when the orthopedic surgeon is called.

The thought of taking on another off-service burden was something that was met with some resistance by a minority of colleagues. We all consider ourselves to be busy all the time, but when we analyzed the total number of patients with hip fractures who are admitted each year, we realized that this was not going to be an overwhelming burden for any individual provider and that it would be a huge benefit to individual patients. The calls would be taken by all providers who covered in-house calls within our institution. Colleagues not on the acute pain service expressed reservations about their ability to actually perform the blocks. To address this issue, we created an education program which was delivered repeatedly to colleagues through didactics and online education. Support was offered to ensure that everyone who might be called to provide this service could comfortably meet the expectations. One of the ways this was done was to provide direct clinical support during weekday calls for these catheters. An acute pain faculty member would accompany a generalist when he or she was placing femoral nerve catheters. In this way, the faculty member could answer questions and provide technical support for this procedure to improve the comfort level and expertise of all anesthesiologists in the department.

In addition, each day our anesthesia technicians ensured that all the equipment necessary was loaded into a bag stored beside the ultrasound machine. The bag contained our peripheral nerve catheter kits, ultrasound gel, consent form (for the nerve block and the surgery the next day), and a check list of all required equipment. Drugs cannot be stocked in the bag per regulations of the Centers for Medicare and Medicaid Services (CMS) and still have to be added from pharmacy before departure for the ER. The stocked bag and checklist minimized inconvenience to the patient as well as off-service providers who have to travel off-site and do not realize what equipment is missing until they arrive in the ER.

 

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Exactech Announces Successful First Surgeries with New ExactechGPS® Total Shoulder Application

September 29, 2016

GAINESVILLE, Fla.–(BUSINESS WIRE)–

Exactech, Inc. (EXAC), a developer and producer of bone and joint restoration products for hip, knee, shoulder and spine, today announced positive surgeon feedback on first surgeries performed with the ExactechGPS® Guided Personalized Surgery system’s new Total Shoulder Application, which combines preoperative planning with intraoperative computer-assisted technology. Pierre-Henri Flurin, MD, a shoulder specialist at the Clinique du Sport in Bordeaux-Mérignac, France, performed both an anatomic and a reverse total shoulder replacement using Equinoxe® Shoulder System implants and instruments.

This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20160929006357/en/

“Our goal is to offer improved accuracy and precision in the placement and orientation of the Equinoxe implants,” said Dr. Flurin. “I was able to plan the case in advance through a virtual simulation and then execute that plan while visualizing the 3-D anatomy in real time, making adjustments based on assessments during surgery. Exactech’s design teams have developed innovative shoulder implants designed to preserve bone and overcome challenges; this new technology is the perfect complement to those implants.”

“In collaboration with our team of engineers located in Florida and France, Dr. Flurin and the rest of the design team brought brilliant expertise to our effort,” said Darin Johnson, Vice President of Marketing, Extremities. “Visualizing the glenoid vault in real time and adjusting the implant orientation to the unique anatomy of the patient should help surgeons improve patient outcomes, which is what we come to work every day to do.”

The shoulder application focuses on guiding the preparation of the glenoid in shoulder arthroplasty. There is wide variation in the position and orientation of glenoid implants because of limited exposure and poor operative landmarks, and studies show that inaccurate placement of the glenoid component has been linked with increased stresses in the implants1, early loosening and poor outcomes.2 The goal of the new ExactechGPS Total Shoulder Application is to allow surgeons to avoid those issues, ultimately providing longer implant survivorship.

Exactech worked closely with a design team of experienced upper extremity specialists to develop this system: Emilie Cheung, MD, Stanford University Department of Orthopaedics (Palo Alto, Calif.); Pierre-Henri Flurin, MD, Clinique du Sport (Bordeaux-Mérignac, France); Richard Jones, MD, Southeastern Sports Medicine (Asheville, N.C.); Moby Parsons, MD, Seacoast Orthopedics and Sports Medicine (Somersworth, N.H.); Paul Saadi, MD, Dallas Bone and Joint Clinic (Dallas, Texas); Thomas Wright, MD, University of Florida Department of Orthopaedics and Rehabilitation (Gainesville, Fla.); and Joseph Zuckerman, MD, NYU Hospital for Joint Diseases (New York, N.Y.).

The ExactechGPS Total Shoulder Application is being piloted in Europe and is currently undergoing premarket review by the FDA.*

About ExactechGPS

ExactechGPS combines surgeon expertise with an advanced computer system to perform the patient’s surgery with a goal of improved accuracy and precision. Personalized for a patient’s unique bone structure and anatomy, ExactechGPS is designed to allow surgeons to decide where to remove bone and place the implant in the optimal position. Exactech first introduced ExactechGPS to surgeons in the United States for knees, and has since broadened its reach by providing medical education and supporting surgeries in more than 11 countries. The technology has steadily gained market acceptance and worldwide reach.

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.

Movement Is Medicine for Patients Suffering From Osteoarthritis

By ALTERG – September 28, 2016

Is it possible for those with osteoarthritis (OA) to avoid or delay hip and knee replacement surgery through physical therapy and exercise? Studies show that minimizing OA pain and getting people moving improve function and may delay the need for surgery. With the help of technology, physical therapists can encourage movement by decreasing or eliminating pain for these OA patients.

OA is the breakdown of cartilage that results in pain, swelling, decreased range of motion and stiffness. The most common chronic joint condition, OA impacts more than 27 million Americans. One in four Americans will develop hip OA by age 85, and one in two will develop knee OA in his or her lifetime.

Many people with OA feel the condition is inevitable, can’t handle the pain and become sedentary while waiting for a surgical intervention. Consider the pain cycle: Pain -> Decreased Movement-> Loss of Flexibility and Strength -> Deconditioning -> Poor Lower Extremity Mechanics. This pain cycle often leads to a sedentary lifestyle, which also results in an increased risk for diabetes, weight gain/obesity, coronary artery disease (CAD), hypertension and falls.

The vision of the American Physical Therapy Association (APTA) is to transform society by optimizing movement to improve the human experience. For those with OA, a physical therapist can help patients break the pain cycle and improve their quality of life by:

  • Encouraging mobility
  • Helping improve flexibility and strength
  • Helping maintain cartilage health
  • Helping normalize gait

Because cartilage is avascular and aneural, there is not a lot of blood flow in cartilage or excessive pain until it breaks down enough to expose the bony layer beneath it. Cartilage exists to absorb shock and withstand pressure, and loading it enough is important for cartilage health, just as load is important for all body tissue. While excessive loading is detrimental to someone with OA, moderate exercise with loads that are pain-free have proven beneficial.

 

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CT Surgeon gives patients pain relief with an innovative procedure to treat stress fractures

(DANBURY, CT) – September 9, 2016 – When his knee quickly swelled to three times its normal size after falling on the stairs, Nicholas Saccone of Carmel, NY knew something was seriously wrong. Saccone, 69, wasn’t able to walk or bend his knee and pain radiated throughout his leg. He immediately contacted Dr. Daniel Fish, a surgeon with Orthopaedic Specialists of Connecticut who had performed previous meniscus surgery on him.
An MRI and X-ray revealed that Saccone had arthritis and had also developed a stress fracture of the knee, but instead of a full knee replacement, Dr. Fish suggested a relatively new procedure called Subchondroplasty. Dr. Fish and two other doctors with Western Connecticut Health Network (WCHN) are among only a handful of surgeons in Connecticut trained to use this revolutionary technique.
“This procedure is ideal for patients with knee pain and decreased joint function caused by small cracks or stress fractures,” explained Dr. Fish. “We inject a calcium phosphate compound that seals the crack, similar to caulking.”
Specifically, surgeons use an injectable, bone graft substitute material called AccuFill® that is intended to fill voids or gaps in the skeletal system. It flows readily to fill bone defects, then crystallizes and sets to form a scaffold in the bone. The compound promotes new bone growth and is naturally replaced with the new bone during the healing process. The FDA approved the material in 2010.
According to the Centers for Disease Control and Prevention (CDC), 719,000 Americans had a full knee replacement in 2010. That same year, the National Center for Health Statistics released a report that shows hospitalization rates for knee replacements more than doubled over a ten year period for adults aged 55-64.
Dr. Fish and his partner Dr. Robert Daher, and colleague Dr. Matthew Rogell, have offered the procedure for the past two years.

“Before Subchondroplasty, there were limited treatment options for this type of injury,” said Dr. Rogell. “Often the only treatment option for patients in significant pain was a more invasive knee replacement.”
For Saccone, his operation was performed at 7:00 a.m. and by noon he was back in his home and able to move around.
“On just the fourth day after my surgery, I was walking without a cane. I couldn’t believe it.” Saccone said. Eight months later, Saccone remains very active, walking 1 ½ miles per day. He just returned from a trip to Atlantic City where he easily walked up and down the boardwalk.
The minimally invasive surgery is a 30-minute outpatient procedure performed under regional anesthesia, so the patient remains awake. The knee can be quite uncomfortable for 24-48 hours after the procedure, but then the pain resolves rapidly. Patients are on crutches for three to five days postoperatively. Most see a complete recovery in four to six weeks.

“Studies have indicated that the benefits can last for more than five years,” Dr. Fish said. “Additionally, this procedure will not limit treatment options for a partial or full joint replacement further down the road if needed.”
Dr. Fish is an examiner for the American Board of Orthopedic Surgery as well as an editorial reviewer for The Journal of Bone & Joint Surgery and the American Journal of Sports Medicine.

“Reviewing the latest research for publication in national orthopedic journals,” he said, “allows me to stay current while evaluating the risks and benefits of new technologies.” Dr. Fish has not yet performed the Subchondroplasty procedure on other weight-bearing joints such as the hip or ankle but he said the potential exists.
Dr. Fish and Dr. Daher are partners at Orthopedic Specialists of Connecticut, based in Brookfield, CT. They both reside in Ridgefield, CT. Learn more by visiting www.ctorthopaedic.com. Dr. Rogell is a partner with Connecticut Family Orthopedics based in Danbury. He resides in Redding, CT. For more information about Dr. Rogell, contact www.cfortho.org.

Western Connecticut Health Network (WCHN) is the region’s premier, patient-centred health care organization built for the people we serve in Western Connecticut and adjacent New York. WCHN is anchored by three nationally recognized hospitals, Danbury Hospital, New Milford Hospital and Norwalk Hospital, with the continuum of outpatient health and wellness services offered by numerous medical practices and sub-specialties across the region through the Western Connecticut Medical Group, the Western Connecticut Home Care. Committed to learning and innovation, our hospitals collaborate with the University of Vermont Medical College and many other well-known academic institutions to promote the most progressive care possible. The nationally renowned WCHN Research Institute, the WCHN Foundation and Norwalk Hospital Foundation and other affiliates complete the WCHN family where We Know You Well! For more information, visit TheNewWCHN.org. Share your comments with us at Facebook.com/DanburyHospital; Facebook.com/NewMilfordHospital and/or Facebook.com/NorwalkHospital.

New SonicOne® O.R. Data Being Presented at WUWHS 2016 Congress: Shows Effectiveness in Removing Biofilm

FARMINGDALE, N.Y., Sept. 26, 2016 /PRNewswire/ — Misonix, Inc. (NASDAQ: MSON), an international ultrasonic surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic instruments for spine surgery, neurosurgery and other surgical specialties, today announced new data demonstrating the effectiveness of the SonicOne O.R. ultrasonic debridement device in removing biofilm from potentially contaminated surfaces associated with metal knee and hip implants. The data will be presented during the World Union of Wound Healing Societies (‘WUWHS”) to be held September 25 – 29, 2016 in Florence, Italy.

It is estimated that 90% of chronic wounds contain bacteria and fungi living within biofilm. The new data suggests SonicOne O.R. can play a role in addressing the significant problem biofilm plays in preventing chronic wounds from healing.

“The early data are very encouraging. The studies showed complete removal of biofilm from infected titanium plates. The plates simulated biofilm that grows on metal knee and hip implants. Biofilm formation and removal is a significant problem in infected implants,” said Dr. Mark S. Granick, Professor and Chief, Division of Plastic Surgery, Rutgers New Jersey Medical School. Dr. Granick added, “While more studies are needed, SonicOne continues to demonstrate utility as an infection control platform during wound debridement.”

Stavros Vizirgianakis, Interim Chief Executive Officer of Misonix, commented, “We are pleased that the SonicOne O.R. system is being recognized as a viable solution to a recurring problem that can profoundly impact the quality of life for the growing number of implant recipients throughout the world. It is gratifying that globally recognized experts like Dr. Granick are involved in this ongoing research. The SonicOne O.R. features unique attributes that can enhance healing in diabetic ulcers, wounds from burns and now, potentially, implant infections. We look forward to the forthcoming results of the ongoing research.”

Misonix also announced a Live YouTube event from Florence, Italy featuring Dr. Granick’s presentation during the World Union Wound Healing Society Meeting. The Live event can be viewed at https://www.youtube.com/embed/VZ3udLGk0e4 on Monday, September 26th at 5 pm EST.  The presentation is expected to cover the clinical benefits of the use of the newly launched SonicVac® addition to the SonicOne O.R. device.  The SonicVac, which was launched in April of this year, uniquely combines aspiration and ultrasound during wound debridement. This combination reduces spray during the procedure while capturing debris and bacteria from the wound.

“We’re particularly excited that Dr. Granick is hosting this event and we look forward to his live presentation at WUWHS 2016 for a worldwide audience.  Events like this are an important part of the Misonix education platform and will expose clinicians from around the world to our unique technologies,” states Scott Ludecker, Senior Vice President, Global Sales and Marketing with Misonix.

The SonicOne O.R. System is an innovative ultrasonic surgical debridement system that allows surgeons to address the challenges chronic wounds present to them, the patient and the healthcare system. SonicOne O.R. establishes a new standard in surgical wound bed preparation, an essential first step in the wound healing process.  The new SonicOne procedure will be sold and distributed through the Misonix sales team in the United States and its domestic and international distribution networks.

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 to be in excess of $1.5 billion annually; Misonix’s proprietary 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 Web site atwww.misonix.com.

Corporate Contact
Misonix Contact:  Investor Contact:
Richard Zaremba Joe Diaz
631-694-9555 Lytham Partners
invest@misonix.com 602-889-9700
info@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 completion of the investigation related to identified deficiencies in internal control over financial reporting, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Logo – http://photos.prnewswire.com/prnh/20160201/328020LOGO

 

SOURCE Misonix, Inc.

Related Links

http://www.misonix.com

Stryker Hip Replacement Helpline Recall Alert

FORT LAUDERDALE, Fla.Sept. 23, 2016

 

Stryker Hip Replacement Metal V 40 Femoral Heads Recall Alert
Stryker Hip Replacement Helpline is gearing up for a nationwide outreach to all people to alert them to the fact that Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. This affects the Exeter, Citation, Meridian, Reliance, Definition, Restoration, Accolade Rejuvenate and ABG 2 stems. The Helpline want to inform all Stryker Hip Replacement recipients that failure of these heads is caused by corrosion and metal debris at the junction between the metal head and neck. The clinical results for patients include pain, loss of mobility, ambulation problems and an inability to work. Poisoning of the soft tissue, muscle and bone are the cause. Revision surgeries are needed due to premature failures. Patients with V40 metal heads that suffer hip poisoning have substantial medical and legal needs.

This is a major undertaking to locate all patients with a Stryker Hip Replacement to be a part of the expected lawsuits for complications such as wear debris, metallosis, joint destruction, infection and need for additional revision surgeries.

The Stryker Hip Replacement Helpline is gearing up for what they feel is a second round of Stryker Hip Replacement lawsuits. “We expect a new wave of T.V. ads by lawyers. Patients will see lawyer ads on T.V. and they will have a lot of questions. They want to speak to someone they feel safe and comfortable with and they call us,” says the helpline medical social worker at 1 877 522-2123.

The outreach is a massive undertaking for the Stryker Hip Replacement Helpline. Their mission is clear and they are ready. They expect to be adding 5-10 new cities a week until they have the major cities in the U.S. covered. The helpline is seeking all people Implanted with a Stryker Exeter, Citation, Meridian, Reliance, Definition, Restoration, Accolade Rejuvenate and ABG 2 stems who are starting to have complications or whose physicians have received the recall letter from Stryker. If you have a Stryker hip replacement, we suggest you contact your physician to find out if they have received the letter and to confirm what type of hip replacement you have. Call the helpline immediately after that.

Stryker Hip Replacement Helpline Recall Alert Outreach Begins

Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. Specifically, these metal heads are associated with wear debris, metallosis, joint destruction, infection and need for revision surgery.

The first round of Stryker V40 femoral heads recall Outreach is projected to reach the following cities:

New York, N.Y.,
Los Angeles, Calif.,
Chicago, Ill.,
Houston, Texas,
Philadelphia, Pa.,
Phoenix, Ariz.,
San Antonio, Texas,
San Diego, Calif.,
Dallas, Texas,
San Jose, Calif.,

Second Stryker Hip Replacement V40 femoral heads Outreach Campaign

Jacksonville, Fla.,
Indianapolis, Ind.,
San Francisco, Calif.,
Austin, Texas,
Columbus, Ohio,
Fort Worth, Texas,
Charlotte, N.C.,
Detroit, Mich.,
El Paso, Texas,
Memphis, Tenn.,

Third round Stryker Hip Replacement V40 femoral heads recall outreach alert

Baltimore, Md.,
Boston, Mass.,
Seattle, Wash.,
Washington, DC,
Nashville
Denver, Colo.,
Louisville,
Milwaukee, Wis.,
Portland, Ore.,
Las Vegas, Nev.,

Additional Lawsuits Outreach

Oklahoma City, Okla.,
Albuquerque, N.M.,
Tucson, Ariz.,
Fresno, Calif.,
Sacramento, Calif.,
Long Beach, Calif.,
Kansas City, Mo.,
Mesa, Ariz.,
Virginia Beach, Va.,
Atlanta, Ga.,
Colorado Springs, Colo.,
Omaha, Neb.,
Raleigh, N.C.,
Miami, Fla.,
Cleveland, Ohio,
Tulsa, Okla.,
Oakland, Calif,.
Minneapolis, Minn.,
Wichita, Kan.,
Arlington,

Stryker Hip Replacement Recall Alert

Stryker has voluntarily recalled some of their metal V40 femoral heads used with hip implants. Specifically, these metal heads are associated with wear debris, metallosis, joint destruction, infection and need for revision surgery. Stryker Hip Replacement Helpline has a dedicated number for assistance 1 877 522-2123 or contact us using the contact form of the website.

http://strykerhipreplacementhelpline.com/

Contact
Lisa Spitzer MSW
***@strykerhipreplacementhelpline.com

PROFILE – Musculoskeletal New Ventures Conference (MNVC)

A Conversation with Gary Stevenson, Co-Founder and Managing Partner at MB Venture Partners, LLC

Let’s start by having you give a brief background on who you are, what MB Ventures is and why you started MNVC.

My name is Gary Stevenson and I am co-founder and managing partner of MB Venture Partners in Memphis. We started in 2001 and raised our first fund in 2002. In our first 15 years, we have focused a disproportionate amount of our investment capital on the musculoskeletal niche where we have domain expertise and relationships that have resulted in high-quality investment opportunities. Over the years, our start-ups have been acquired by Wright Medical, Medtronic, Smith & Nephew, and Zimmer Biomet.

One of our venture partners, with the help of the Memphis Bioworks Foundation, started in the MNVC in 2003, so this will be our 14th annual event. The goal then was to feature the relative strengths of Memphis in the musculoskeletal industry. MB Venture Partners has been Conference Host and the largest sponsor every year since then. Our goal is to bring together the 20-25 most exciting new start-ups so they can engage with investors (both venture capitalists and angels) and strategic partners (Medtronic, Smith & Nephew, Wright Medical, and may others).

 

MNVC being October 18-19th, it falls right in the middle of the busy season for orthopedic industry meetings, yet many of us industry “junkies” consider MNVC to be a “Can’t Miss” meeting. Why do you think that is?

I appreciate the compliment – I do think MNVC is the “can’t miss” event of the year for musculoskeletal start-ups and the people who love them. We don’t aim to be the largest event of the year, but we do want to be the best. As one example, we give presenters plenty of time at the podium to tell their story – 30-minute time slots. This is less superficial than other events and allows the depth that industry insiders are looking for. I think insiders want more than a 6-minute or 10-minute presentation can give them and that’s one reason why we all come to the MNVC. That and the barbecue.

 

What kind of companies typically present at MNVC?

We strive for balance when we curate the presenter list. It’s by invitation only and we’re looking for a mix of spine and orthopedics. We’re also looking for a mix of early and later-stage opportunities. We have been told many times that the MNVC is the one place where start-ups like to “break stealth”, that moment in time when management thinks they’re ready to tell the industry more about what they’re up to. We’re flattered to hear that, obviously.

 

Tell our readers about the beneficiary of the meeting proceeds and your passion about giving back to your community.

As returning attendees already know, MB Venture Partners doesn’t host the MNVC with an eye towards making a profit. If we were, we would be selling presentation slots (they’re free) and we’d be dividing the hour into 6 10-minute slots or even worse, 10 6-minute slots. Also, we don’t hire an outside firm to manage the conference for us. Truth is, MB Venture Partners donates all of its time putting the event on every year and pays for the privilege – we’ve written the largest sponsorship check every year. We do all that because we’re trying to keep costs low. A portion of each year’s proceeds is donated each year to the Memphis Academy of Science and Engineering (“MASE”), Tennessee’s first charter school. MASE helps inner-city students achieve their dream of a job in the technology and medical device fields. MASE was founded by the Memphis Bioworks Foundation and it warms our heart to know that more than $120,000 has been donated from the MNVC to benefit the teachers and students of MASE.

 

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Medical Device Testing Services Expands Orthopaedic Capabilities

MINNETONKA, Minn., Sept. 20, 2016 /PRNewswire/ — Medical Device Testing (MDT) Services has added spine and knee wear testing to its extensive orthopaedic device testing portfolio.  For the past 26 years, MDT has served the medical device industry as a contract test laboratory focused on mechanical testing and materials characterization.

MDT was founded in 1990 as a division of EnduraTEC Systems Corporation, which specialized in the development of novel material test instruments for the medical device community.  In 2000, MDT was spun off as a separate company to provide greater focus on testing services.  MDT is an ISO 17025 certified laboratory that provides test design, execution, and documentation using a rigorous quality program that helps customers fast-track their submissions to the FDA and other regulatory agencies.

MDT recently added an MTS Bionix Spine Wear Tester and multiple Knee Motion Wear Simulators to expand capabilities in orthopaedic medical device testing.  While MDT has a strong brand recognition in the medical device market for cardiovascular device testing, a significant part of its business has always been in orthopaedics.  “In fact, the very first applications we worked on when we launched the company in 1990 were spinal fixation device fatigue testing and knee motion simulation.  Over the last 26 years, we have been fortunate to work with the most original device designs targeting applications from head to toe,” saidKent Vilendrer, President and CEO of MDT.

About Medical Device Testing Services

Medical Device Testing Services is one of the largest A2LA accredited medical device testing companies in the world with over$6 million in commercial fatigue and durability test systems, inspection instruments, and test fixturing inventory.  Find out more about the medical device mechanical testing and materials characterization specialists at www.devicetesting.com.

 

SOURCE Medical Device Testing Services