Active Implants SUN Clinical Trial for Persistent Knee Pain Now Underway in San Diego

June 07, 2017

SAN DIEGO–(BUSINESS WIRE)–Active Implants, a company that develops orthopedic implant solutions, today announced that the company’s SUN (Safety Using NUsurface®) trial is now underway in San Diego. Dr. Scott A. Hacker at Grossmont Orthopaedic Medical Group is the only physician in San Diego County – and the center is one of just 10 sites nationwide – participating in the SUN clinical trial to evaluate the investigational NUsurface Meniscus Implant (pronounced “new surface”) for the treatment of persistent knee pain caused by injured or deteriorating meniscus cartilage.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“Current treatments for meniscus-related chronic knee pain do not address the underlying biology of the knee pain,” Dr. Hacker said. “Injections and medications do provide temporary relief for some patients but are just masking the symptoms. We hope this study finds that the NUsurface implant addresses the underlying problem and gets rid of the discomfort, allowing patients to return to the leisure and work activities that had been hindered by pain.”

The SUN study will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Oska® Wellness Honored with MedTech Breakthrough Award

CARLSBAD, CA, June 7, 2017 – Oska Wellness, a technology company committed to developing consumer health and wellness products, announced that its Oska Pulse has been selected as the “Best IoT Healthcare Wearable Device” award winner from MedTech Breakthrough, an independent organization that recognizes the top companies, technologies and products in the global health and medical technology market.

“All of us at Oska are excited to receive this award from MedTech, who have recognized Oska’s mission to provide non-invasive, drug-free pain management solutions,” said Greg Houlgate, Oska Wellness CEO. “This is an important industry recognition for our year-old company and our flagship device, Oska Pulse. We’re very grateful.”

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Patient Engagement, Electronic Health Records (HER), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 2,000 nominations from more than 10 countries. All nominations were evaluated by an independent panel of experts within the medical and health industry, including media, analysts, and technology executives.

“We are thrilled to recognize Oska Wellness with this well-deserved industry recognition for innovation in the health and medical technology field,” said James Johnson, managing director, MedTech Breakthrough. “For the millions of Americans that suffer from chronic pain, Oska Pulse is a compelling solution and the MedTech Breakthrough Award designation is a testament to the skill, ingenuity, and vision of the Oska Wellness team.”

Oska Pulse is a safe, easy-to-use, portable and wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

About Oska Wellness 
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

About MedTech Breakthrough
The MedTech Breakthrough Awards program is devoted to honoring excellence in medical and health related technology companies, products and people. The MedTech Breakthrough Awards provide a platform for public recognition around the achievements of breakthrough MedTech companies and products in categories including Patient Engagement, mHealth, Health & Fitness, Clinical Administration, Healthcare IoT, Genomics, Medical Data, Healthcare Cybersecurity and more. For more information visit www.MedTechBreakthrough.com

 

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Exactech Announces Successful First Surgeries with New Equinoxe® Preserve Stem and ExactechGPS® Shoulder Application

June 06, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today a successful first surgery using the new Equinoxe® Preserve stem, a conservative shoulder treatment option designed to preserve humeral bone in shoulder replacement surgery. Additionally, surgeons performed the first U.S. procedures using the ExactechGPS® Shoulder Application.

Orthopaedic surgeon Thomas Wright, MD, performed the first Preserve stem surgery in Gainesville, Fla. “The surgical team and I were pleased with the results of today’s surgery, including the thoughtful implant design, practical instrumentation and relatively simple technique,” Dr. Wright said.

The Preserve stem expands the options offered by the successful Equinoxe®Platform Shoulder System. This new stem is approximately two-thirds the length of the system’s current stem.

“Creating a bone preserving stem that can be used alongside already clinically successful components of our Equinoxe anatomic and reverse implants is an important evolutionary step in our perpetual pursuit of improved clinical outcomes,” said Darin Johnson, Vice President of Marketing, Extremities.

The implant design was developed through the use of CT reconstruction data and clinical studies. Specifically, the implant features a unique polished distal tip to facilitate any need for removal, a straight lateral fin designed for greater rotational stability and plasma coating to aid proximal fixation.

“The technique and implant were created to provide a more bone preserving option within the Equinoxe suite. It was a great pleasure over the last couple of years to collaborate with Drs. Samuel Antuna, Ken Faber, Howard Routman, Joseph Zuckerman and Pierre-Henri Flurin on this innovative improvement. This product demonstrates Exactech’s commitment to working closely with surgeons to improve patient outcomes,” Dr. Wright said.

Dr. Wright and Richard Jones, MD, of Asheville, N.C., also completed the first U.S. surgeries using the ExactechGPS Shoulder Application, a computer-assisted shoulder arthroplasty technology. “This advance in shoulder arthroplasty – being able to execute a preoperative plan in the operating room with real-time visibility into the glenoid vault – has almost limitless possibilities to help patients. Ten years ago, Dr. Sean Grey and I implanted the first Equinoxe reverse shoulder, and that innovation set the pace for the last decade. Now, I believe, ExactechGPS is the breakthrough for the next decade,” Dr. Jones said.

Full U.S. market availability for the Preserve Stem and ExactechGPS Shoulder Application is planned for the beginning of 2018.

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.

A current investment profile on Exactech (Nasdaq: EXAC) is available online at http://www.hawkassociates.com/profile/exac.cfm. To receive future releases in e-mail alerts, sign up at http://www.hawkassociates.com/about/alert.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

Contacts

Exactech
Investor contacts:
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Hawk Associates
Julie Marshall or Frank Hawkins, 305-451-1888
EXAC@hawkassociates.com
or
Exactech
Media contact:
Priscilla Bennett, 352-377-1140
Vice President, Corporate & Marketing Communication

Life Spine® Achieves Record Breaking Sales Growth of Biologics Product Line over Past Year

June 06, 2017

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 exponential growth of their Biologics product line, OSTEO-LINK™ Demineralized Bone Matrix, over the past fiscal year.

“OSTEO-LINK has been engineered and processed to deliver the highest level of osteoinductivity. It is because of this technology that we have achieved record breaking revenue growth of 424% over the past year,” said Mariusz Knap, Vice President of Marketing for Life Spine. “From April to May alone, we experienced a 270% revenue jump. This has been possible through our many differentiated offerings of putty, strips, cubes and fillers all available to help influence better patient outcomes and reduce costs.”

Life Spine expects continued growth of their Biologics line with the announcement of two new Biologic offerings. First, OSTEO-LINK Hydratable ICM (Inductive Carrier Matrix), which is an osteoinductive bone matrix that may be hydrated with saline, blood, BMA, or PRP. OSTEO-LINK Hydratable ICM does not contain any extrinsic carriers and is made from 100% human bone. The graft also has exceptional handling characteristics that resists irrigation. All OSTEO-LINK products are verified for osteoinductivity post-sterilization prior to release for distribution. In-vivo test results demonstrate all 5 bone forming elements present (chondrocytes, osteocytes, bone marrow cells, cartilage, and new bone).

Second, the patent pending MARROW CELLUTION™ Bone Marrow Harvesting System, designed to overcome the limitations of a traditional bone marrow needle and results in a bone marrow harvest that is so rich in key stem and progenitor cells that the aspirate may no longer require manipulation through centrifugation prior to application. Traditional needles produce excess peripheral blood contamination, diminishing cellular yield; thereby requiring additional manipulation steps to achieve the cellular demand necessary for most clinical indications. MARROW CELLUTION uses its patent(s) pending technology to harvest high quality stem and progenitor cells from various levels within the marrow space, while limiting peripheral blood contamination.

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.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

Oska® Wellness Teams Up With Arizona Golf Association to Promote the Revolutionary Oska Pulse

CARLSBAD, Calif., May 31, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing innovative consumer health and wellness products, is partnering with the Arizona Golf Association to promote Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain.  The AGA is comprised of more than 400 clubs and 75,000 members.

“I used Oska Pulse both prior to and after my hip surgery last year,” said Ed Gowan, Executive Director of the AGA.  “We’re always interested in bringing new products and options to Arizona Golf members. If they can use Oska Pulse to play one more round, then we’re all for recommending it to our community.”

Oska Pulse is a safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

“I met Ed Gowan in 2010 while in the golf industry and am delighted to forge an official relationship with the Arizona Golf Association,” said Steve Collins, COO of Oska Wellness. “The AGA shares our mission for new ways to provide non-invasive, drug-free pain management solutions. Many golfers have told us that they’ve had to cut back on playing due to elbow, hip, wrist, knee, back pain and more. Those who have used Oska Pulse now view the device as just as important to managing their aches and pains as a putter or a driver is to his or her game.”

The Arizona Golf Association was founded in 1923 as a small group of golfers who got together to run the annual Amateur Championship.  The AGA is a volunteer-based organization directed by amateur golfers, dedicated to promoting the game of golf, and providing valuable benefits and services to its members.

During the PGA Merchandise Show in January, Oska Wellness introduced Oska Pulse, a hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology to help people enjoy more active, pain-free and drug-free lives.  Subsequently, Oska Pulse was named “best in show” by top golf publications, including Golf Digest.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

CONTACT:
Robin Carr, Oska, Inc.
415-971-3991
162247@email4pr.com

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Dr. Brian Badman is First and Only Indiana Shoulder Surgeon to Offer Breakthrough Treatment for Rotator Cuff Tears

American Health Network today announced that Dr. Brian Badman is the first and only shoulder surgeon in Indiana to treat patients suffering from rotator cuff disease using the Rotation Medical Bioinductive Implant – a new technology that helps tendons heal through the induction of new tissue growth, potentially helping patients resume normal activities quicker than traditional treatment and reducing the likelihood of further degeneration or re-tears.

The minimally invasive system is designed as a new option for people suffering from rotator cuff tendon tears in the shoulder joint, which affect more than 4 million people annually in the U.S. and are the most common source of shoulder pain and disability.

“Rotator cuff injury is common, and many patients avoid surgery because they hear about painful, lengthy postoperative rehabilitation and time away from work,” said Dr. Brian Badman. “The Rotation Medical Bioinductive Implant, which is about the size of a postage stamp, is inserted through a small incision during a minimally invasive arthroscopic outpatient procedure. The Bioinductive Implant induces the formation of new tendinous tissue over the surface of the tendon, resulting in a thicker tendon. Depending on their stage of rotator cuff disease, the Bioinductive Implant can provide patients a range of potential benefits, including shorter rehabilitation, faster recovery, prevention or slowing of disease progression, healing of partial-thickness tears, and decreased risk of developing a subsequent tear.” Several prominent orthopedic shoulder surgeons across the country have helped pioneer this technology including Dr. Jeff Abrams at Princeton and Dr. Buddy Savoie at Tulane University.

Rotator cuff tears are most often caused by chronic wear and tear with degeneration of the tendon. Rotator cuff tears can also occur in people who repeatedly perform overhead motions in their jobs or sports. In fact, more than 50 percent of people over age 60 have symptoms related to rotator cuff partial to full tearing of the tendon. Because traditional treatments do not address the poor quality of the underlying tendon tissue, a significant number of these tendons often develop into larger, more painful and debilitating tears and/or re-tears due to continuing degeneration of the torn tendon. The Bioinductive Implant allows surgeons to intervene early and potentially prevent disease progression by augmenting and healing the tendon before the injury worsens.

The Bioinductive Implant, manufactured by Rotation Medical, is suitable for most rotator cuff disease, from small partial-thickness tears to massive full-thickness tears. The Bioinductive Implant is derived from bovine Achilles tendon and gradually absorbs within six months, leaving a layer of new tendon-like tissue to biologically augment the existing tendon. This treatment can be used for both previously treated and untreated patients. Introduced to the market in 2014, the technology has been used in thousands of rotator cuff procedures in the U.S.

For more information, please visit Indyshoulder.com or to schedule an appointment with Dr. Badman, please call 317-208-3866.

About Dr. Badman
Dr. Badman grew up in South Bend, Indiana. He completed his orthopedic residency training at the University of Florida-Gainesville in 2005 and finished a shoulder and elbow fellowship at the Florida Orthopedic Institute in Tampa in 2006. Dr. Badman joined American Health Network (AHN) in 2011 as the founding member of AHN’s Bone & Spine group. He has subspecialty interest in shoulder and elbow disorders, with specialty training in arthroscopic rotator cuff repair, shoulder instability, total shoulder arthroplasty, reverse shoulder arthroplasty and proximal humeral fracture fixation. He is a member of the American Shoulder and Elbow Society and is only the fourth person from Indiana to be inducted into this prestigious international group of shoulder specialists. Over the past several years, Dr. Badman has consistently been one of the busiest reconstructive shoulder surgeons in the state, performing more than 150 replacement surgeries per year (total and reverse) and over 250 arthroscopic rotator cuff repairs annually.

About American Health Network’s Bone & Spine Group
American Health Network’s bone & spine physicians deal with diagnosis and treatment of diseases and injuries of the musculo-skeletal system, which includes bones, joints, muscles, ligaments, and tendons. The group provides fully integrated state-of-the-art care from diagnosis and treatment to rehabilitation. For more information, visit http://www.indyboneandspine.com

Kuros Biosciences submits MagnetOs Putty for US FDA Clearance

06 Jun 17

Kuros (SIX:KURN) today announced it has filed the submission package for MagnetOs Putty seeking 510(k) clearance from the US Food and Drug Administration (FDA) for use as an autograft extender in posterolateral spine. MagnetOs is a novel synthetic bone graft substitute designed to support bone healing in the implanted site in the body. MagnetOs Putty is a moldable putty formulation of MagnetOs Granules, which is already cleared for commercialization in the United States of America and the European Union.

Dr. Ivan Cohen-Tanugi, Chief Executive Officer of Kuros, commented: “This FDA filing is yet another important milestone for Kuros as it eventually expands our portfolio of commercial-stage products. A similar submission for MagnetOs Putty in the EU will be filed in the next months.” He continued: “MagnetOs features a unique surface science technology that supports local bone formation. To meet surgeons’ preferences, we are developing a comprehensive product line consisting of different formulations and applications of MagnetOs. Furthermore, we plan to extend the existing labels into additional indications.”

MagnetOs Putty advantage

According to Kuros estimates, there are over 3 million procedures worldwide each year that use a bone graft material or a substitute. Patient-own bone (autograft) is still considered the gold standard bone grafting material. However, harvesting healthy bone usually requires a separate surgical procedure with associated costs, risks and morbidity.  Therefore, an extender that can be used in combination with local autograft, without the need for a separate autograft harvest procedure, offers significant potential benefits. Animal testing demonstrates comparable rates of bone healing for MagnetOs when used as an extender with autograft compared to autograft alone in a rabbit posterolateral fusion model.

Oska® Wellness Teams With MyTPI to Promote Oska Pulse

CARLSBAD, Calif., May 17, 2017 /PRNewswire/ — Oska Wellness, a technology company committed to developing innovated consumer health and wellness products, is partnering with MyTPI to promote Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain. MyTPI has the largest collection of golf-specific health, fitness and swing advice on the Internet.

“We’re excited to be working with MyTPI, sharing our mission for new ways to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness.  “We’ve heard from many golfers who have had to cut back on playing due to pain. But thanks to the use of Oska Pulse, golfers can play one more round, pain free. Oska Pulse is a smart, safe, easy-to-use, wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain, and increase mobility for people who have acute or chronic pain.”

During the PGA Merchandise Show in January, Oska Wellness unveiled the Oska Pulse — a small, portable, hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology, a longtime therapy used by medical practitioners to help people enjoy more active, pain-free and drug-free lives.  Subsequently, Oska Pulse was named “best in show” by several leading golf publications, including Golf Digest.

“I’ve used Oska Pulse and got great results with mobility and pain relief from this device,” said David Phillips, co-founder of TPI.  “Our partnership with Oska Wellness will allow us be able to promote Oska Pulse to our leadership team, our affiliates, and our athletes. I’m a total believer in this product and I look forward to recommending it to our community.”

Phillips also said there are several ways to use the device. “After a round of golf, if you feel lower back pain or perhaps you have some wrist tendonitis,” he said. “Or prior to play, if you feel a little tightness in the morning. Use Oska Pulse on your way to the course.”  Developed by the experts at the Titleist Performance Institute, MyTPI.com delivers advanced golf-specific information from experts on six continents and 62 countries.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with over 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

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CONTACT:

Robin Carr, Oska, Inc.
415-971-3991
160282@email4pr.com

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/oska-wellness-teams-with-mytpi-to-promote-oska-pulse-300459069.html

Oska® Pulse is a “Best Product” Award Winner at ING Conference

CARLSBAD, CA, June 1, 2017 – Oska Pulse, a breakthrough wearable electromagnetic field device that eases pain, was recently named “Best Product” at the 27th Annual ING Spring Conference. Oska Pulse, the flagship product from Oska Wellness, received the award last month at the World Golf Village & Hall of Fame in St. Augustine, FL.

The ING Spring Conference is an annual gathering of media and golf industry executives conducted by the non-profit networking organization, the International Network of Golf. A group of 130 industry executive and media were in attendance at this years’ event, held May 21- 24.  The Oska Pulse and the Knuth Golf High Heat fairway metals tied in voting by attendees who chose their favorite products which were demoed at the conference.

“We are thrilled to be honored by the folks who attended the ING Conference and who recognize Oska’s mission to provide non-invasive, drug free pain management solutions,” said Greg Houlgate, CEO of Oska Wellness. “It was an inspirational week at the conference, and we heard from golfers who deal with elbow, hip, wrist, knee, back pain and more. With Oska Pulse, golfers can play another round — pain free.”

During the PGA Merchandise Show in January, Oska Wellness introduced Oska Pulse, a hands-free device that employs safe Pulsed Electromagnetic Field (PEMF) therapeutic technology to help people enjoy more active, pain-free and drug-free lives. Oska Pulse was named “best in show” by top golf media outlets who attended, including Golf Digest, Golf Channel, and TravelingGolfer.net.

Oska Pulse is a safe, easy-to-use, portable and wearable health technology product designed to help reduce muscle stiffness, temporarily relieve minor pain and increase mobility for people who have acute or chronic pain.

About Oska Wellness
Oska, Inc. is committed to developing health and wellness technology-driven products that assist individuals in living a more active, pain-free lifestyle. Oska Pulse utilizes patented eTec Pulse Technology that specifically optimizes Pulsed Electromagnetic Field (PEMF) therapeutic technology, similar to the PEMF therapies used in many clinical applications for accelerating the body’s ability to heal itself.

The science and technology behind Oska Pulse was engineered and developed by a team of respected scientists and researchers with more than 25 years of experience in engineering health and wellness technologies to treat pain. Oska Wellness, Inc. does not claim the product to diagnose, treat, cure or prevent any medical condition. The company is headquartered in Carlsbad, California and can be found online at www.oksawellness.com.

 

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Accelerant Venture Capital Fund Approves Investment in AMB Surgical

June 1, 2017

DAYTON, Ohio – The Accelerant Venture Capital Fund recently approved investment in AMB Surgical to support the company’s development of a prototype for its Flyte Automated Growing Rod, a medical device that could revolutionize the way physicians treat juvenile scoliosis, lengthen limbs, and stabilize traumatic injuries.

The company founders bring decades of engineering experience to their work, as well as a personal mission to make such surgeries less traumatic for young patients.

Founder Casel Burnett would know. His daughter was diagnosed with juvenile scoliosis as a young child and endured years of invasive surgeries as part of the treatment. Scoliosis, or curvature of the spine, can lead to life-long health issues if not corrected while the child is still growing. Watching his daughter undergo treatment motivated him to find a better way.

“AMB embodies the innovative spirit and hard work that characterize the Dayton Region,” said Roger Edwards, Vice President of Accelerant Venture Capital Fund, an initiative of the Dayton Development Coalition. “Their work has the potential to revolutionize the way these conditions are treated and spare young patients repeated, invasive procedures.”

Burnett is a mechanical engineer and group manager of production engineering at Toyota, and partnered with friend Tyson Ross, an electrical controls engineer and program manager at the U.S. Air Force Research Laboratory, to see how they could take the existing technology and improve it. Ross and Burnett are confident they have found the answer.

AMB uses patented technology to electronically control the extension of rods used in orthopedic surgeries. Current devices use manual adjustments, either by having caretakers, such as parents, use tools to adjust an external framework for limb extension, or, for scoliosis, through repeated back surgeries. A physician implants an adjustable rod along the child’s spine, and as the child grows, uses tools to lengthen the rod through additional surgeries to correct the curve.

Flyte would allow the physician to expand the rod remotely, without surgery, as the child grows, both cutting down on the number of surgeries and potentially accelerating the treatment. It would eliminate the need for parents to adjust external frames, as well as reduce the likelihood of missing adjustments.

The key to their technology is tiny gear box located in the rod that has a microchip and RFID reader to program adjustments and record information.

Dr. Michael Albert, Director or Orthopaedics at Dayton Children’s Hospital, called the product a “game changer” in this type of treatment.

“We have made significant progress in the safety and design of limb lengthening external fixator devices, but what has been lacking is an automated, safe and reliable device that removes the patient or family from making daily adjustments,” Dr. Albert wrote in a letter of support for AMB.

Ross said they plan to develop a prototype with the current round of funding, starting with a rod that would be used in external frames, then moving on to implanted rods for scoliosis treatment and other internal uses.

For physicians, the device would also provide valuable feedback they can’t access today. The same technology that allows the device to adjust, allows it to collect data on the patient’s progress. The company already holds patents on the technology, and the initial research and design have generated interest from world leaders in pediatric orthopedic surgery.

“How small can we go? That’s the real question,” Ross said. “There’s tremendous potential for this type of technology, and we are confident we can bring it to market.”

The product would need to undergo testing and approval from the Federal Drug Administration.

The investment marks the 10th investment for Accelerant, the region’s only institutional VC fund with resources ready to invest in local companies. AMB has attracted significant “sidecar” investment as well, as private local investors find increasing opportunities to invest in start-ups in the Dayton Region.

“In the last year, we’ve seen a real shift in funding for local start-ups,” Edwards said. “The support and investment of local ‘angel investors’ is vital for start-ups to flourish. It’s exciting to connect local entrepreneurs to investors in the Dayton Region so they can grow their businesses here.”

AMB’s technology has generated interest from outside the Dayton region, as well. Dan Sands, a 25-year healthcare industry executive, has identified and is retaining world-renowned surgeon advisors, subject matter experts in engineering, accredited investment sources, and potential strategic commercialization entities.

“The positive market interest for this technology has been extraordinary,” said Sands, CEO of D11, LLC, who has spent most of his career in Warsaw, Ind., a city known within the industry as the “Orthopaedic Capital.” “Flyte’s ability to give surgeons real-time biomechanical stress/strain data will allow more accurate and timely remote non-surgical adjustments. This represents a game changing advancement in orthopaedics and could lead to a new frontier in bionic implantable devices that improves the total cost and quality of care.”

AMB plans to engage The Ohio State University’s Center for Design and Manufacturing Excellence and other expert resources as part of its efforts to develop the initial productionready prototypes. The Ohio State center plans to leverage its expertise to facilitate design feasibility, component and systems development, prototyping, manufacturing scale, and workforce development. “Working with Ohio State’s CDME brings resources and expertise to the process at an early stage that is difficult to find elsewhere in the country,” Ross said.

As for the young girl who inspired this technology, Burnett’s daughter Ashley Mae is all grown up, working as a nurse, and in great health. She’s the name behind AMB.

“We started down this path to help her, and I hope the work we’ve done will give children an easier journey than she had,” Burnett said. “We’re grateful for the support we’ve found here in Dayton and are excited to move forward with this opportunity.”

Dayton Development Coalition (DDC) is the leading economic development organization for the 14- county Dayton region. Working closely with public and private regional partners, its mission is to retain, expand and recruit jobs. The DDC and the Dayton region ranked as the nation’s top metro for its size for economic development in 2008, 2009 and 2012 and runner-up in 2010, 2011, 2014 and 2015. With the State’s largest single-site employer in its backyard, the DDC also focuses on advocating for the critical missions at Wright-Patterson Air Force Base and supporting the work of the United States Air Force. The DDC was ranked as America’s top military community, and was presented with the 2015 Community Excellence Award from the Association of Defense Communities. It was designated as one of the ADC’s Great American Defense Communities in 2016 – a testament to the collaborative efforts in support of Wright-Patt, America’s #1 Air Force Base as ranked by the Air Force Times (2014). For any questions regarding the DDC, contact Shannon Joyce Neal at (937) 723-2047. For more information on AMB, contact Dan Sands, 574-527-1525, or dan.sands@outlook.com.

For any questions regarding the DDC, contact Shannon Joyce Neal at (937) 723-2047. For more information on AMB, contact Dan Sands, 574-527-1525, or dan.sands@outlook.com.