Chandler, Arizona —- As it prepares for its commercial product launch in Europe and new clinical studies in the United States, SalutarisMD® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) will be in the spotlight at the 2016 AZBio Awards on September 21, 2016 as they are honored with the AZBio Fast Lane Award.
The following day, on September 22, 2016, Dr. Laurence Marsteller, SalutarisMD® CEO will provide further updates to investors from across the United States at the White Hat Life Science Investor Conference.
Wet AMD is the leading cause of blindness worldwide and there is an urgent and compelling need for new therapies that improve visual outcomes and lower the burden of care.
SalutarisMD® is a pre-revenue medical device company developing an investigational ophthalmic treatment for Wet Age-related Macular Degeneration (Wet AMD). SalutarisMD®’s patented technology incorporates a minimally invasive single-use brachytherapy procedure that can be performed in an outpatient setting in approximately 15 minutes. The patented and patent pending technology delivers a single-use brachytherapy procedure. SalutarisMD®’s technology is being engineered to deliver improved outcomes for Wet AMD.
LIFE in the Fast Lane
SalutarisMD®, an Arizona founded and grown company, is poised for success!
On September 8, 2016, SalutarisMD® introduced its new generation, commercial ready, episcleral brachytherapy applicator system at the Ophthalmology Futures European Forum in Copenhagen, Denmark. The presentation by Dr. Laurence Marsteller, CEO, shared how the new SalutarisMD® system (SMD-DA™) is designed to deliver improved dosimetry to wet AMD lesions and improved ease of use for retinal surgeons. ISO audits for certification and CE application are underway and the Company expects to receive ISO 13485 certification and the CE Mark on the commercial product by year end.
The Company also recently received US regulatory approval for an upcoming clinical study utilizing the new and improved device. The company has successfully completed a previous study with a first generation clinical device. While that study was not intended to be extrapolated for statistical significance, individual subject results were tracked. In three of the four treatment-naïve patients and one of the two chronically treated wet AMD patients, best corrected visual acuity (BCVA) improved at two years following SMD-1™ treatment (range: +4 to +25 ETDRS letters). In addition, two treatment-naïve patients did not require any further anti-VEGF injections during the following two years.
In June of 2016, SalutarisMD® was selected as a winner in the Arizona Innovation Challenge. The company won the maximum award of $250,000.
The AIC, funded by the Arizona Commerce Authority, awards the most money in the country for a technology commercialization challenge. A panel of expert judges evaluates applications and assesses each on a set of criteria including technology potential, marketing strategy, quality of management team and economic impact. This business plan competition awards capital to talented, innovative start-up and early stage companies to grow their business.
“It is exciting to see Arizona’s entrepreneurial ecosystem continue to grow and produce impressive startup companies, and the ACA is proud to support them,” ACA President and CEO Sandra Watson said in a statement. “Our rigorous selection process ensures that the best and brightest startups thrive in Arizona – and their success continues to showcase Arizona as a leader in innovation.”
“Winning this prestigious award has accelerated our efforts to treat those suffering with the debilitating disease of wet age-related macular degeneration with our minimally invasive device. We are using the AIC award funds in our efforts towards manufacturing and export distribution,” remarked Dr. Laurence Marsteller, SalutarisMD® CEO.
In March 2015, SalutarisMD® received a strategic investment from HOYA Corporation of Japan, a major multi-national interventional ophthalmology company with a $15.6 billion market cap. That investment has been a driving force behind our recent successes and has enabled the company to grow internally and prepare for commercialization.
Over the past 18 months, SalutarisMD® has received a 510(k) on its first device, hired an in house engineering team to develop its commercial device, completed a clinical trial in London, UK at Moorfields Eye Hospital, and implemented an ISO 13485 quality system. SalutarisMD was recently recommended for ISO 13485 certification by the notified body BSI.
The Arizona Bioindustry Association created the AZBio Fast Lane Award in 2011 to recognize companies that have achieved outstanding milestones in the past 18 months. Significant progress can be measured by clinical results, regulatory approvals, certifications, collaborations, funding awards, product launches, job growth or product sales milestones.
“We believe that it takes more than just a great idea to create a great company,” said Koerber-Walker. “It takes a team that knows how to map the course, execute on a plan, and get results. We are happy to welcome SalutarisMD® to the Fast Lane where they join a cadre of successful life science companies that are moving forward faster and working to make life better for patients.”
“This progress towards commercialization is a testament to the dedicated work of our team and the ongoing support of our investors,” stated Dr. Marsteller. “Our new commercial ready applicator system is a significant marker of SalutarisMD®’s continued progress and we are looking forward to positively affecting patient outcomes.”
SalutarisMD® will be honored during the 11th Annual AZBio Awards at the Phoenix Convention Center on September 21, 2016, in front of an audience of local, national, and international leaders.
###
For registration and more information, go to www.azbioawards.com
For more information on Arizona Bioscience Week, visit www.AZBio.org/AzBW
About AZBio
A key component in Arizona’s life science ecosystem, the Arizona Bioindustry Association (AZBio) is the only statewide organization exclusively focused on Arizona’s bioscience industry. AZBio membership includes patient advocacy organizations, life science innovators, educators, healthcare partners and leading business organizations. AZBio is the statewide affiliate of the Biotechnology Innovation Organization (BIO) and works in partnership with AdvaMed, MDMA, and PhRMA to advance innovation and to ensure that the value delivered from life-changing and life-saving innovation benefits people in Arizona and around the world.
For more information visit www.AZBio.org and www.AZBio.TV
About SalutarisMD®
SalutarisMD® (Salutaris Medical Devices, Inc. and Salutaris Medical Devices, Ltd.) is a pre-revenue medical device company developing an investigational ophthalmic treatment for wet age-related Macular Degeneration (wet AMD). The SalutarisMD patented technology incorporates a minimally invasive single-use brachytherapy procedure that can be performed in an outpatient setting in approximately 15 minutes. This method delivers localized tissue irradiation that is performed under the direct care and expertise of a retina specialist. For more information visit www.SalutarisMD.com or www.SalutarisMD.co.uk.
Caution: Investigational Device. Limited by Federal Law to Investigational Use in the United States.
Salutaris Medical Devices, Inc.
4340 N. Campbell Ave.
Suite 266
Tucson, AZ 85718
+1 520-638-7518
www.SalutarisMD.com
Salutaris Medical Devices, Ltd.
Level 1, Bessemer Building Imperial College
London SW72AZ +44 (0) 203 282 7166
www.SalutarisMD.co.uk
Contacts:
SalutarisMD
Joanne Vitali, US Communications Director
+1 610-518-5405
jvitali@SalutarisMD.com
AZBio:
Joan Koerber-Walker, Arizona Bioindustry Association
jkw@azbio.org 480-332-9636
Amanda Vega
Amanda@AmandaVega.com (480) 275-9797
Photos available upon request.