Neuros Medical enrolls first patients in clinical study for post-amputation painPosted by BioOhio on Jan. 28, 2015
Neuros Medical announced today that it has enrolled the first patients in its pivotal clinical trial to evaluate the Altius System, patented high frequency nerve block technology for the management of intractable limb pain of amputees.
The study will consist of up to 130 patients at 15 institutions to evaluate the safety and efficacy of technology. When completed, the results will support a PreMarket Approval Application to FDA in order to market the device. The study builds off their long-term pilot study which reported significant pain reduction, up to 30 months. In addition, more than half of the responders discontinued their pain medication use during the study.
“The Neuros High Frequency Nerve Block has the opportunity to be a paradigm shift in treating chronic pain, especially post-amputation pain, due to its on-demand blocking effect, versus traditional stimulation,” said Dr. Leonardo Kapural, the study’s principal investigator, from the Carolinas Pain Institute in Winston-Salem, North Carolina.
Dr. Nagy Mekhail, Director of the Evidence Based Pain Medicine Research, Department of Pain Management at Cleveland Clinic added, “We are honored to be one of the initial implanting sites and part of this important study to investigate the Altius technology for patients with post-amputation pain.”
“We are excited to have our first implants underway as we execute our pivotal study, with our wave of sites commencing recruitment and enrollment,” stated Jon J. Snyder, President and CEO of Neuros Medical.
Repeal of the medical device tax is a big deal for innovation and jobsPosted by BioOhio on Jan. 28, 2015
According to reports released today by the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA), repeal of the ACA’s medical device tax would benefit innovators and employers across the country.
MDMA conducted a survey of medical technology innovators to assess how repeal of the medical device tax would impact their operations. The survey included over 100 responses from senior executives at some of the United States’ most innovative and entrepreneurial medical device companies.
- 72% of companies slowed or halted job creation in the United States to pay the medical device tax
- 85% of respondents said that if the device tax was repealed, they would hire new employees in the U.S.
- 80% of respondents noted that they would increase R&D investments in the cures and therapies of tomorrow
- When asked how much they would increase their R&D budget, the average increase was 14%
AdvaMed’s survey details the negative and costly impact of the medical device tax, reflecting the tough choices companies are making to address it including reducing jobs, R&D and other financial investments. Here are just a few of their findings:
- Employment reductions of approximately 18,500 industry workers
- Forgone hiring of 20,500 additional employees over the next five years
- 46% said they would consider further employment reductions if the tax is not repealed
- 71% said they would reinstate forgone hiring if the tax were repealed
- 53% said they had reduced R&D as a result of the tax
- Many respondents would consider further or first-time reductions in R&D if the tax stays in effect, but would reinstate projects or make new investments in R&D if the tax were repealed
Both the House and Senate recently introduced bipartisan pieces of legislation to repeal the medical device tax in the 114th Congress.
BioOhio is the Ohio affiliate for global bioscience associations AdvaMed, BIO, MDMA and PhRMA.
AdvaMed advocates on a global basis for the highest ethical standards, timely patient access to safe and effective products, and economic policies that reward value creation.
The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies.
BioOhio BioBulletin, January 2015Posted by BioOhio on Jan. 23, 2015
Welcome to the January 2015 BioBulletin! This edition marks the one year anniversary of this monthly e-publication.
Trivia: Did you know this weekend Columbus is hosting the National Hockey League (NHL) All-Star Weekend? Some stats: $12 million expected visitor spending; 140,000 attendees; 8,000 hotel-room nights booked by the NHL; 150 countries in which the game will be televised; 400 members of the media attending; $50 million estimated value of media exposure. Go Blue Jackets!
This edition of features Membership Updates, BioOhio Education Summit & Career Fair, NHLBI Regional Innovation Conference, BioOhio Statehouse Day, Event Updates, Sponsorship Opportunities, Talent & Training Programs, Advocacy Updates, Savings Programs and a wrap up of the News!
We proudly welcome 9 new members since the December edition of BioBulletin! Thanks for joining Chromocare, Early Stage Partners, HIMSS Innovation Center, Kaleidoscope, Kulis Freeze Dry, Slone Partners, Synergy Health, and two individuals.
February 9 in Columbus
BioOhio, in partnership with Southwest Ohio Bioscience Education Consortium and The Ohio Academy of Science, is hosting the Bioscience Talent, Workforce & Education Summit. The goal of this event is to gather the state’s educators, school administrators, career counselors, workforce professionals and industry representatives to discuss the quality, comprehensiveness, and challenges of bioscience education in Ohio.
Assurex Health selects Mason, Ohio for expanded headquartersPosted by BioOhio on Jan. 22, 2015
Fast growing BioOhio member company Assurex Health, makers of the GeneSight treatment decision support platform, just announced that it has chosen to remain in Mason, Ohio with a 60,000 sq.ft. expansion to their headquarters serving as both a corporate office and genomics laboratory.
“We are elated to hear the news,” said John F. Lewis, Jr., President and CEO of BioOhio, “Assurex Health continues to be one of Ohio’s fastest rising stars in the bioscience industry. Backed by the strength of their technology, team and the community here in Ohio, the sky is the limit for Assurex.”
The new facility is expected to be completed by 2016 and will accommodate significantly more staff and an expanded, state-of-the art diagnostic laboratory. In the past three years, Assurex Health has tripled its employment to 240 and quadrupled the number of patients that have received its GeneSight tests to more than 130,000.
In today’s announcement, Virginia C. Drosos, President and CEO of Assurex Health explained the company’s decision to stay at home in Mason.
“The access to top talent, strong science partnerships with Cincinnati Children’s Hospital Medical Center and regional universities, and the cost structure — including the affordable lifestyle and incentives that Mason and Ohio offer — could not be matched,” Drosos said. “We love the entrepreneurial and venture-backed ecosystem in the region and are committed to the growing biohealth corridor here. It is an outstanding platform on which to build our company and support our work to assist healthcare providers in helping their patients achieve mental wellness.”
“Five other states approached us about relocating and the City of Mason, the Regional Economic Development Initiative (REDI) Cincinnati, and the State of Ohio partnered to work around the clock to keep us here,“ said Don Wright, Chief Operating Officer. “They have been extremely helpful in identifying locations and developing the incentives essential to making the project possible. The quality of life and culture of wellness that Mason and the region offer were important factors as well.”
“We deeply value the partnership we have cultivated with Assurex Health,” said City of Mason Mayor David F. Nichols. “Our relationship with Assurex Health speaks directly to the entrepreneurial environment we have developed in Mason.”
“Assurex Health’s decision to significantly expand its workforce in Mason confirms Ohio is home to a rapidly growing biohealth industry,” said John Minor, JobsOhio President and Chief Investment Officer. “We are proud of our strong relationship with this pioneering company as it expands in our state and positively impacts the lives of people throughout the world.”
“Assurex Health is an important job creator in our region,” said Johnna Reeder, President and CEO of REDI Cincinnati. “We believe Assurex Health is a true success story – and will not only continue to contribute jobs, but will encourage other high-potential health and technology startups and companies to Greater Cincinnati.”
MIDMARK celebrates 100 years in businessPosted by BioOhio on Jan. 21, 2015
BioOhio would like to extend our sincerest congratulations to Midmark Corporation as they celebrate 100 years in business!
Midmark, a family business headquartered in Dayton, offers an extensive array of products for the medical, dental and veterinary markets. Complete product lines cover many aspects of patient care and medical staff needs – including power procedure and examination tables, seating, lighting, workstations, sterilization, and casework materials.
In a recent media release, Midmark’s President and CEO, Dr. Anne Eiting Klamar, congratulated her Midmark teammates on their achievement, “We are thrilled to be celebrating our 100th year as a company. We are grateful for our rich history, but are even more excited for the future ahead of us. We are building a future that is even greater than our past, cultivating a culture that is ready to seize opportunity, relying on our strong foundation to drive our vision of creating a better healthcare experience for all.”
Midmark began in 1915 manufacturing cement mixers, later expanding to mining locomotives, foundry equipment and custom metal fabrications. John Eiting, Klamar’s great-grandfather, was the first member of the Eiting family to hold a leadership position. Her father, Jim Eiting, joined the company in 1956, developing a new strategy which led Midmark to Versailles, Ohio and into the medical industry when the company acquired a line of medical examination tables. Today Midmark employs more than 1,600 worldwide.
“Midmark has proven to be a true Ohio success story” said BioOhio President & CEO John F. Lewis, Jr. “With a strong history of innovation and dedication to quality manufacturing, Midmark is well positioned to easily celebrate another 100 years. We’re honored to have Midmark as a member and look forward to continuing to be engaged with them in the future.”