News
Bluegrass Vascular parts with global company as it seeks profitability
Publication: San Antonio Business Journal
Bluegrass Vascular’s CEO, Gabi Niederauer, presents @ LSI USA ’22 Emerging Medtech Summit
Gabriele Niederauer, CEO of Bluegrass Vascular Technologies, Inc., presented at the recent LSI ’22 Emerging Medtech Summit. An exciting event that recognized our success to date and our efforts with the Surfacer® Inside-Out® Access Catheter System to improve vascular access outcomes for hemodialysis patients.
Link to video of Gabi’s presentation: https://www.lifesciencemarketresearch.com/videos/bluegrass-vascular-technologies
Bluegrass Vascular scores millions in new investor funding
Publication: San Antonio Business Journal
Bluegrass Vascular Closes $5M in Convertible Debt Financing
Publication: Startups San Antonio Business Journal
Big federal win clears wide market for San Antonio’s Bluegrass Vascular
Publication: San Antonio Business Journal
San Antonio company picked for elite global medtech accelerator
Publication: San Antonio Business Journal
Surfacer System featured as lead story in Vascular Specialist, Official Publication of the SVS
The lead story in the March 2020 issue of the Vascular Specialist features an interview with Eric Peden, M.D. about the Surfacer System and the device’s recent FDA De Novo clearance. Dr. Peden is Division Chief and Program Director for Vascular Surgery at the Houston Methodist DeBakey Heart & Vascular Center. He was also a principal investigator in the SAVE-US IDE study which generated clinical data supporting Surfacer System’s regulatory submission in the U.S.
The article in the Vascular Specialist, an Official Publication of the Society for Vascular Surgery (SVS), provides a history of the development of the Surfacer System and insights from Dr. Peden on the device’s role in obtaining central venous access in patients with central venous obstructions. Dr. Peden comments that the Surfacer device is “really exciting technology for really challenged dialysis patients.”
Click here to read the entire article.
FDA clears SA biotech’s first medical device for use in U.S.
Publication: San Antonio Business Journal
TechTonics: Medical Device Startup CEO Eyes Regulatory OK After Years-Long Wait
Publication: Rivard Report
Canadian First Establishes Central Venous Access from the Inside-Out
Publication: UHN
UHN becomes the first center in Canada to establish central venous access using the Surface Inside-Out Catheter System.
Bluegrass Vascular Technologies Named Top 10 Nephrology Solution Providers of 2019
Publication: MedTech Outlook
MedTech Outlook recognizes Bluegrass Vascular Technologies as a pioneer at the forefront of medtech innovation by naming the company as one of the top 10 nephrology solution providers of 2019.
Results Presented for Bluegrass Vascular’s Surfacer Access Catheter System
Publication: Endovascular Today
Bluegrass Vascular Technologies announced the presentation of results for its Surfacer Inside-Out access catheter system in a poster session at the 2018 American Society of Nephrology annual meeting held October 23–28 in San Diego, California.
Bluegrass Vascular Expands SAVE-US IDE Trial and Completes Enrollment in European Post-market Registry
Publication: Endovascular Today
Bluegrass Vascular Technologies has completed enrollment of the prospective, multicenter, international, post–CE Mark approval SAVE registry, which is evaluating the company’s Surfacer system to facilitate access in venous occlusions. The Surfacer system received CE Mark approval in 2016.
Bluegrass Vascular launches pivotal study for Surfacer vascular access catheter
Publication: Mass Device
Bluegrass Vascular Technologies said it enrolled the first patients in a pivotal trial of its Surfacer “inside-out” vascular access catheter. The Surfacer device is designed to provide access to the jugular vein to restore central venous access in hemodialysis patients with blocked neck veins; it won CE Mark approval in the European Union in August 2016; Bluegrass later inked an EU distribution deal with Merit Medical (NSDQ:MMSI) that included an equity stake.
Merit Medical to market Bluegrass Vascular’s catheter system in Europe
Publication: FierceBiotech
Bluegrass Vascular nabbed a CE mark for its “inside-out” central venous catheter last summer. Now, the company is tapping Merit Medical to “streamline” the distribution of the device in Europe. “We are very pleased to be partnering with Merit Medical, a prominent distributor of medical devices in Europe and the U.S. that shares the same vision of addressing the clinical gaps that exist in vascular access care for hemodialysis patients,” said Bluegrass CEO Gabriele Niederauer, in a statement.
Innovations: Surfacer Inside-Out Access Catheter System
PUBLICATION: Endovascular Today Europe
A preview of today’s new products: Bluegrass Vascular Technologies, Inc. announced that it has received CE Mark approval and has launched a limited commercial sale of its Surfacer Inside-Out access catheter system in Europe. The Surfacer system is indicated for obtaining central venous access to facilitate catheter insertion into the venous system via a novel inside-out approach.
San Antonio firm creates innovative catheter system
MEDIA: KLRN PBS – SciTech Now
SciTech Now, a PBS newsmagazine program, explores the innovative Surfacer Inside-Out Access Catheter System, created by Bluegrass Vascular Technologies. The video depicts the Surfacer System, which recently received CE Mark approved for use in the European Union market.
Bluegrass Vascular announces CE mark approval and successful commercial use of Surfacer Inside-Out access catheter system
Publication: Vascular News
Bluegrass Vascular Technologies has received CE mark approval and is launching limited commercial sale of its Surfacer Inside-Out access catheter system. The Surfacer system is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel “Inside-Out” approach.
Bluegrass Vascular’s Surfacer Inside-Out Access Catheter System Approved in Europe
Publication: Endovascular Today
Bluegrass Vascular Technologies announced that it has received European CE Mark approval for its Surfacer Inside-Out access catheter system, which is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via an “inside-out” approach. The Surfacer system is available in limited markets, including the United Kingdom, Germany, Austria, Italy, and the Benelux countries.
Lifesaving European premier
PUBLICATION: Badische Zeitung
Article written and published in German. Under special compassionate use permission in Germany at the Ortenau Klinikum in Offenburg-Gengenbach, a 73-year-old female patient with end-stage renal disease and requiring dialysis to survive was referred to the Ortenau Klinikum for the novel Surfacer System procedure.
Bluegrass device moving closer to market
PUBLICATION: San Antonio Business Journal
San Antonio-based Bluegrass Vascular Technologies is making some significant headway outside the U.S. The biotech firm has moved closer to securing a CE Mark, regulatory approval that would allow Bluegrass Vascular to commercialize its initial medical device, the Surfacer Inside-Out Access Catheter System, in Europe.
SA biotech firm making critical progress in Europe with first medical device
PUBLICATION: San Antonio Business Journal
Bluegrass Vascular Technologies Inc. has taken a critical step toward commercialization of its initial medical device — the Surfacer Inside-Out Access Catheter System. Gabriele Niederauer, president and CEO of the private medical technology company, which is based in San Antonio and focused on vascular access technologies, said a European medical team has now successfully used its Surfacer System on a patient with life-threatening complications from end-stage renal disease.
Ten Life Sciences Companies to Watch in Central Texas
PUBLICATION: Silicon Hills
Bluegrass Vascular Technologies – the San Antonio-based startup relocated from Lexington, Kentucky. It raised $4.5 million in Series A financing last year led by the Targeted Technology Fund of San Antonio. The company makes the Surfacer, a central venous access catheter system. Gabriele Niederauer joined the company in September of 2014 as its CEO and President.
San Antonio developing biotech executive talent
PUBLICATION: San Antonio Express News
Serial entrepreneurs are those who take on the risks of building a company good enough to be sold to an older, larger company and taking the proceeds to start another company. An example of such an executive in San Antonio’s health care and medical devices sector is Gabriele Niederauer, now CEO and president of Bluegrass Vascular Technologies Inc.
Forecast: Three San Antonio biomedical companies to watch in 2015
PUBLICATION: San Antonio Business Journal
Bluegrass Vascular Technologies is developing a special catheter system that enables physicians to gain venous access to a patient using a novel approach. The company moved from Kentucky to San Antonio last year after closing on $4.5 million in funding and then hired Dr. Gabriele Niederauer, a seasoned senior medical device executive, as its president and CEO.
San Antonio biotech firm Bluegrass Vascular Technologies secures new leadership
PUBLICATION: San Antonio Business Journal
Bluegrass Vascular Technologies has been quite busy of late by closing on a new round of funding and hiring a new chief executive to lead the biotech company. In late July, I reported that the Kentucky-based medical technology company had closed on $4.5 million in new investor funding and was relocating to San Antonio.
Inside-Out Upper Body Venous Access: First in Human Experience with a Novel Approach Using the Surfacer System
PUBLICATION: Cath Lab Digest: Volume 22 – Issue 3, March 2014
Severe renal dysfunction and venous occlusive disease is a major cause of morbidity, mortality, and increased medical costs, especially within the dialysis population. The long-term risks of central venous access include occlusion, which can occur within days of catheter placement and is a common problem in patients requiring repeated access or semi-permanent access.
Inside-Out Upper Body Venous Access. The first-in-human experience with a novel approach using the Surfacer inside-out access catheter system
PUBLICATION: Endovascular Today
Severe renal dysfunction and venous occlusive disease are major causes of morbidity, mortality, and increased medical costs, especially within the dialysis population. The long-term risks of central venous access include occlusion, which can occur within days of catheter placement and is a common problem in patients requiring repeated access or semipermanent access. Central venous occlusion can deprive patients of vital therapies such as hemodialysis, cardiac pacing, chemotherapy, and drug infusion.
Bluegrass Vascular Technologies: Novel “inside-out” approach to central venous access
PUBLICATION: Start-Up Magazine
Although central venous catheters are commonly employed to lever long-term dialysis, nutrition and chemotherapy, nearly 10% of patients have an upper extremity venous occlusion that renders the vein impenetrable by standard access techniques.
In the right vein
PUBLICATION: BusinessLexington
When he was president of the University of Kentucky, Lee Todd strongly encouraged faculty members to take their original ideas to the next step and turn them into new businesses and jobs to better the commonwealth. One company to emerge from the minds of UK personnel was technology incubator Therix Medical. And now, Therix has managed to spin off a company of its own – Bluegrass Vascular Technologies (BVT), which develops and commercializes devices and methods that improve vascular access procedures.
Bluegrass Vascular focuses on Surfacer ‘inside out’ catheter
PUBLICATION: Medical Device Daily
Medical technology incubator Therix Medical (Lexington, Kentucky) reported the launch of spin-out Bluegrass Vascular Technologies, a stand-alone company specializing in life-saving devices and methods that address shortcomings in vascular access procedures. Bluegrass Vascular Technologies’ flagship product is the Surfacer inside-out access catheter system, an instrumentation set that allows physicians to perform a novel “inside-out” approach to gain venous access
Therix Medical Spins Out Bluegrass Vascular Technologies
PUBLICATION: Endovascular Today
Therix Medical (Lexington, KY), a medical technology incubator, announced the spin-out of Bluegrass Vascular Technologies, a stand-alone company dedicated to developing and commercializing devices and methods that address shortcomings in vascular access procedures.
Inside-out access: A new method of lead placement for patients with central venous occlusions
PUBLICATION: HeartRhythm, Journal of the Heart Rhythm Society, Volume 8, Issue 6, Pages 851-857
Physicians will increasingly encounter patients who require rhythm management devices but have venous obstructions that prevent conventional access. Alternate access options, such as thoracotomy or transiliac approaches, exist but are associated with greater cost and morbidity.