News

Advanced Catheter Therapies Receives Third FDA 510(k) Clearance on Occlusion Perfusion Catheter
New Clearance Offers Potential for Significant Cost Savings

 
CHATTANOOGA, TN, December 1, 2016 – Advanced Catheter Therapies, Inc. (ACT), today announced that its Occlusion Perfusion Catheter™ (OPC) has received a third 501(k) clearance from the U.S. Food and Drug Administration (FDA). This new indication allows the OPC, a universal targeted therapeutic agent delivery catheter, to be repositioned for the delivery of various agents for multiple treatments with the same patient. Current treatments for restenosis may require the use of multiple devices such a drug-coated balloon or drug-coated stent for the same patient.
 
“The ability to deploy the OPC multiple times for the same patient not only saves money by reducing the number of catheters required, it adds even more control and versatility for the clinician and has the potential to streamline the delivery of treatments for restenosis and other diseases such as AV fistulas, targeted cancer therapies, lytic therapies and venous insufficiencies,” said Paul Fitzpatrick, CEO of ACT. “This confirms our belief that the OPC, which has five U.S. patents as well as multiple international patents – the most recent being from India – is positioned to be the next generation of therapeutic agent delivery devices.”
 
Clinical efficiency studies for the OPC are currently underway, and Fitzpatrick says the company is seeing encouraging data with positive results on all endpoints to date. A total of 48 patients have been treated and the device has been used 150 times with multiple positioning.
 
The clinical trials for the OPC are multi-center, prospective, non-randomized controlled trials being conducted by the Horizons International Peripheral Group (HIPG), a membership-based organization comprised of the leading innovators, educators, researchers and advocates for the advancement of the diagnosis and management of patients with Peripheral Vascular Disease (PVD).
 
ACT operates as a highly efficient research and development organization, developing its product line through a phased approach. The company’s role in product development includes design, engineering, prototype development and patent filing. In addition, ACT can move forward human clinical trials, regulatory approval and initial market development.
 
“We are focused on innovation and out-license or sale of each device technology to strategic partners,” said Fitzpatrick. “We are currently looking at licensing the OPC for other fields of use.”
 
The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the targeted delivery of various therapeutic and diagnostic agents to the peripheral vasculature. The OPC, which is disease and agent agnostic, has the ability to create a localized treatment chamber and place the agent circumferentially into the vasculature of the treatment chamber. It is unique in its ability to measure pressure applied inside the treatment chamber.
 
The OPC allows affords clinicians substantial procedural control and the ability to select the treatment agent and volume while significantly limiting systemic release of the treatment agent. The inflow and outflow ports are used for chamber evacuation, filling and flushing, and can also be used to combine and mix agents.
 
In April 2016, ACT announced the signing of a worldwide License Agreement with Toray Industries, Inc. (TORAY) to manufacture, market and sell the OPC for the exclusive field of peripheral vascular stenosis and restenosis.

ACT Receives Third FDA Clearance on OPC_20161201.pdf
click to download

Advanced Catheter Therapies Signs Worldwide License Agreement With Toray Industries, Inc. for the Occlusion Perfusion Catheter®

CHATTANOOGA, TN - (Apr 19, 2016) -  Advanced Catheter Therapies, Inc. (ACT) announced today that it has signed a worldwide License Agreement with Toray Industries, Inc. (TORAY) to manufacture, market and sell the patented and FDA-cleared Occlusion Perfusion Catheter® (OPC), a targeted therapeutic agent delivery system for the exclusive field of peripheral vascular stenosis and restenosis.

ACT is a research and development medical device company with a portfolio of innovative catheter technologies addressing vascular disease and targeted endovascular drug delivery. The company began manufacturing the OPC approximately one year ago to support clinical trials and a targeted test market release.

"Our first-in-human clinical trials have been very encouraging, and we have successfully met our milestones for safety and efficacy," said Paul J. Fitzpatrick, CEO of ACT. "We look forward to working closely with Toray to address a worldwide market for the treatment of peripheral arterial disease (PAD) and targeted drug delivery estimated at about $3 billion by 2020."

"At Toray, we are continually seeking new and innovative ways to treat the most pressing medical needs, such as arterial stenosis and restenosis," said Shigeo Fujimori, Director of TAM Ventures, Limited (TAMV), a subsidiary and a corporate venturing arm of Toray. "We believe the OPC is truly 'generation-skipping' and offers innovative features that overcome the limitations of current technologies to offer a substantial patient benefit."

Terms of the licensing agreement were not disclosed. The OPC remains available for licensing within other fields such as coronary stenosis and restenosis, oncology, dialysis, venous insufficiency and lytic therapy.

ACT and Toray Sign Worldwide Licensing Agreement for OPC_4-19-16.pdf
click to download
Advanced Catheter Therapies Receives Second FDA 510(k) Clearance on Occlusion Perfusion Catheter
 
CHATTANOOGA, TN, September 23, 2015– Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) today announced that its Occlusion Perfusion Catheter™ (OPC) has received its second U.S. Food and Drug Administration (FDA) 510(k) clearance. The patented OPC is a universal targeted therapeutic agent delivery catheter. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting peripheral vascular disease.
 
“ACT is very excited about this second FDA 510(k) clearance for the OPC,” said Mark Rich, VP Business Development for ACT. “With the additional range of sizes, ACT can now offer treatment delivery options for vessels 3mm-10mm in diameter and disease length up to 15cm in length.” ACT is in talks with several potential partners for the licensing rights to bring OPC forward to full commercialization.
 
Earlier this year, the OPC was featured in a live case educational presentation during the 16th Annual New Cardiovascular Horizons (NCVH) Conference. Frank T. Bunch, M.D., F.A.C.C., principal investigator for the IRB-approved COPPER-A & B (The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis) clinical trials, performed the case for the educational discussion.
 
“We strongly feel the OPC, which has a growing intellectual property estate and strong patent protection, is positioned to be the next generation of therapeutic agent delivery devices,” said Paul Fitzpatrick, CEO for ACT.
 
ACT Receives Second FDA Clearance on OPC.pdf
click to download
Advanced Catheter Therapies’ OPC Device Featured in Live Case at NCVH
 
CHATTANOOGA, June 23, 2015 – The Occlusion Perfusion Catheter™ (OPC), a FDA-approved multi-lumen balloon catheter providing targeted intravascular drug delivery, was featured in a live case presentation during the 16th Annual New Cardiovascular Horizons (NCVH) Conference. Frank T. Bunch, M.D., F.A.C.C., principal investigator for the COPPER-A clinical trial, performed the case, which can be viewed on the NCVH website at 1:50 PM. Dr. Bunch also made a presentation on the science behind the OPC at the conference.
 
Rex Teeslink, M.D., the device’s inventor, NCVH faculty member, and scientific advisor for Advanced Catheter Therapies, Inc. (ACT), was present for the live case, something that both he and Dr. Bunch pointed to as a milestone for the device. “It was very exciting to be part of a live case,” said Dr. Teeslink. “It shows attendees that science is progressing beyond drug coated balloons. We believe the OPC represents the next generation of drug delivery devices.”
 
The clinical trial for the OPC is being conducted by the Horizons International Peripheral Group (HIPG), a membership based organization comprised of the leading innovators, educators, researchers and advocates for the advancement of the diagnosis and management of patients with Peripheral Vascular Disease (PVD). COPPER-A is focused on the prevention of restenosis above the knee in the superficial femoral and popliteal arteries, and COPPER-B is also a clinical trial conducted by HIPG for the prevention of restenosis below the knee.
 
“Thus far, we have enrolled three patients in COPPER-A and five in COPPER-B; four of the COPPER-B patients have had 30-day follow-ups, and we received positive results on all endpoints,” said Dr. Bunch, who is with Cardiology Associates in Mobile, AL. “COPPER-A is a multi-center, prospective, non-randomized controlled trial that will enroll 150 patients in up to 10 sites in the U.S. Site selection is progressing as we review patient volume and each center’s ability to meet our inclusion/exclusion criteria.”
 
ACT's OPC Device Featured in Live Case at NCVH.pdf
click to download
Advanced Catheter Therapies Completes Series B Funding with Toray Industries, Inc.

CHATTANOOGA, March 17, 2015 – Advanced Catheter Therapies, Inc. (ACT) announced today that it has completed its $4.5M Series B preferred equity financing round through a strategic investment by TAM Ventures, Limited (TAMV), a subsidiary and a corporate venturing arm of Toray Industries, Inc. (TORAY) in Tokyo, Japan.
 
ACT is a research and development medical device company with a portfolio of innovative catheter technologies addressing vascular disease and targeted endovascular drug delivery. The company recently received the first limited shipment of its lead product, the Occlusion Perfusion Catheter™ (OPC), which is patented and 510(k) cleared, that will be used to support clinical trials and a targeted test market release. 

“This is an eventful, pivotal time for ACT,” said Paul J. Fitzpatrick, CEO of ACT. “The investment from Toray is tremendously exciting, and we look forward to successfully bringing the OPC catheter to market for targeted applications. As part of that effort, we are participating in a clinical trial that will initially include 30 patients.”

“We are continually seeking new and innovative ways to treat the most pressing medical needs, such as arterial stenosis and restenosis,” said Shigeo Fujimori, Director, TAMV. “The very interesting approach taken by ACT has great promise, and we look forward to partnering with ACT to achieve worldwide commercialization of the OPC catheter for select business segments included in Toray’s strategic plan.”
 
ACT Completes Series B Funding with Toray Industries.pdf
click to download
Advanced Catheter Therapies Announces Series B Equity Financing

CHATTANOOGA, August 20, 2014 – Advanced Catheter Therapies, Inc. (ACT) (www.acatheter.com) announced today that its $3 million Series B preferred equity financing has been oversubscribed and the company is expanding the round to $4.5 million.  ACT is now actively seeking to complete the round with an additional $1.1 million. ACT is a research and development medical device company with a portfolio of innovative catheter technologies addressing vascular disease and targeted endovascular drug delivery.
 
The Series B equity financing was provided by a majority of the company’s Series A investors, including ACT I Investments, LLC, a group of Chattanooga-based investors; the Chattanooga Renaissance Fund, a for-profit angel capital fund started and funded by Chattanooga business leaders; and the Maclellan Foundation and its affiliates. New investors include Innova Fund II LP based in Memphis, TN; INCITE Co-Investment Fund, administered by Launch Tennessee; Chattanooga-based DeMoss Alternative Opportunities Fund, LP, and Blank Slate Venture Fund II, LLC; plus a number of Chattanooga-based angel investors.
 
ACT Secures Series B Funding.pdf
click to download
Advanced Catheter Therapies Receives FDA 510(k) Clearance on Occlusion Perfusion Catheter
CHATTANOOGA, TN, October 8, 2013 – Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) today announced that its Occlusion Perfusion Catheter™ (OPC) has received U.S. Food and Drug Administration (FDA) 510(k) clearance. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.

“ACT is very excited about the FDA 510(k) approval for the OPC,” said Paul J. Fitzpatrick, CEO of ACT. “It marks a significant advance for ACT and our lead product, and we look forward finding a partner to move the OPC forward to full commercialization. We strongly feel the OPC, which has strong intellectual property and patent protection, is positioned to be the next generation of therapeutic agent delivery devices.”
Advanced Catheter Therapies Receives FDA 510(k) Approval on Occlusion Perfusion Catheter.pdf
click to download
Advanced Catheter Therapies Awarded Patent
CHATTANOOGA, TN, July 29, 2013 – Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8398589 B2 for its catheter technology. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.

This is the company’s third patent for its Occlusion Perfusion Catheter™ (OPC). The OPC is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the local delivery of therapeutic agents to the peripheral and eventually the coronary vasculature. The device has the ability to create a localized treatment chamber for the delivery of various types of therapeutic agents to treat a variety of disease states and place the agent circumferentially into the vasculature of the treatment chamber.
Advanced Catheter Therapies Awarded Third Patent.pdf
click to download
Advanced Catheter Therapies Seeking $3 Million Series B Equity Financing
CHATTANOOGA, June 5, 2013 – Advanced Catheter Therapies, Inc. (ACT) announced today that it is in the process of raising $3 million in Series B preferred equity financing. ACT is a research and development medical device company with a portfolio of innovative catheter technologies initially targeting vascular disease and restenosis.

In 2011, ACT raised a total of $2.98 million in Series A equity financing through an investment consortium in Chattanooga, TN. The company has already raised a portion of the total amount sought for Series B. The funds will be used for further development of medical devices in ACT’s product pipeline with a focus on moving the patented Occlusion Perfusion Catheter™ (OPC), an intravascular agent delivery device, to sale or out-licensing. ACT has filed for 510(k) approval from the FDA for the OPC.
ACT Series B Financing Announcement.pdf
click to download
Advanced Catheter Therapies Names Scientific Advisory Board
CHATTANOOGA, TN, December 18, 2012 – Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) has announced the members of its Scientific Advisory Board, who will advise and assist the company in the development of current and future pipeline products.

“We are incredibly honored to have been able to attract people of this caliber to serve in an advisory capacity,” said Paul J. Fitzpatrick, CEO of ACT. “Bringing together these thought leaders will have a profound impact on ACT’s ability to develop catheter-based medical devices that improve endovascular procedures. We look forward to their guidance and experience to help accelerate our innovative devices so they can begin to benefit prospective patients as soon as possible.”
ACT Names Scientific Advisory Board.pdf
click to download
Advanced Catheter Therapies Receives Second Patent on OPC
CHATTANOOGA, TN, September 14, 2012 – Advanced Catheter Therapies, Inc. (ACT), (www.acatheter.com) today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8262611 for its catheter technology.

The patent, entitled "Occlusion Perfusion Catheter,” was issued on September 11, 2012 and is closely related to the U.S. Patent No. 8088103 issued to ACT in early 2012 for its catheter technology. The company now has two U.S. patents with a total of 31 claims, one pending U.S. method patent and five pending international patents.
ACT Patent Approved.pdf
click to download
Advanced Catheter Therapies Selects Hatch Medical for Technology Brokerage
CHATTANOOGA, TN, June 18, 2012 – Advanced Catheter Therapies, Inc. (ACT), today announced that it has contracted with Hatch Medical, L.L.C. to assist with licensing the company’s lead vascular catheter product.

“We are extremely excited about the substantial progress we’ve made in the development of the patented Occlusion Perfusion Catheter™ (OPC), and that has encouraged us to move forward with commercializing the OPC, a universal localized therapeutic agent delivery catheter. We are also in the process of filing a 510(k) application with the U.S. FDA for the OPC,” said Paul J. Fitzpatrick, CEO of ACT.

“We believe the OPC represents a next generation platform technology with tremendous potential to disrupt the therapeutic agent delivery markets, including but not limited to drug coated/eluting stents and balloons,” said Paul Gianneschi, Managing Principal and Founder of Hatch Medical.
ACT-Hatch Release.pdf
click to download
Advanced Catheter Therapies Awarded Patent
CHATTANOOGA, TN, January 10, 2012 – Advanced Catheter Therapies, Inc. (ACT), today announced that the United States Patent and Trademark Office has issued U.S. Patent No. 8088103 for its catheter technology.

The patent, entitled "Occlusion Perfusion Catheter,” was issued on January 3, 2012. The Occlusion Perfusion Catheter ™ (OPC™) is a multi‐lumen balloon catheter designed to temporarily occlude a specific region from blood flow to allow the local delivery of therapeutic agents to the peripheral and coronary vasculature. Also in the company’s development pipeline are devices to improve endovascular debulking procedures (the clearing of blocked blood vessels).
Advanced Catheter Therapies Awarded Patent.pdf
click to download
New Name Announced for Atlanta Catheter Therapies
‘Advanced Catheter Therapies’ Result of Move to Chattanooga
CHATTANOOGA,TN, November 1, 2011 – Atlanta Catheter Therapies, Inc., which recently raised a total of $2.98 million in Series A equity financing through an investment consortium in Chattanooga, TN, is changing its name to Advanced Catheter Therapies, Inc. (ACT). The company is an early stage research and development medical device company with a portfolio of innovative catheter technologies targeting vascular disease including thrombosis, inflammation, occlusions and restenosis
New Name Announced for Atlanta Catheter Therapies.pdf
click to download
Atlanta Catheter Therapies Completes $2.98 Million Series A Equity Financing

ATLANTA and CHATTANOOGA, September 29, 2011 – Atlanta Catheter Therapies, Inc. (ACT) has raised a total of $2.98 million in Series A equity financing through an investment consortium in Chattanooga, TN. ACT is an early stage research and development medical device company with a portfolio of innovative catheter technologies targeting vascular disease and restenosis.
Atlanta Catheter Therapies Closes Series A Funding.pdf
click to download
Atlanta Catheter Therapies Receives Grant through
Qualifying Therapeutic Discovery Project
ATLANTA, GA, November 5, 2010 – Medical device company Atlanta Catheter Therapies, Inc. (ACT) has received a grant for almost $250,000 through the Qualifying Therapeutic Discovery Project (QTDP) under the Patient Protection and Affordable Care Act of 2010. A total of $1 billion has been allocated to support biomedical research by small firms.
ACT Receives Grant through Qualifying Therapeutic Discovery Project.pdf
click to download
High Interest from VC Forums in Atlanta Catheter Therapies
Company Selected to Present at SEBIO and Tennessee Valley Venture Forum
ATLANTA, GA, October 25, 2010 – Medical device company Atlanta Catheter Therapies, Inc. (ACT) is generating high interest in its innovative intravascular catheterization which integrates drug delivery. The company has been selected to present at the upcoming 14th Annual Tennessee Valley Venture Forum (TVVF) as well as the Southeast BIO (SEBIO) Investor Forum.
High Interest from VCs in ACT.pdf
click to download
Atlanta Catheter Therapies Selected for Investor Conferences
ATLANTA, GA, and BOSTON, MA, April 19, 2010 – Atlanta Catheter Therapies, Inc. (ACT) has been selected to present at the Biotech & Healthcare Venture Summit 2010, presented by youngStartup Ventures, in Boston on April 20, 2010. ACT is focused on developing innovative catheter technologies targeting vascular disease and restenosis.
ACT Selected for Investor Conferences.pdf
click to download
Innovative Vascular Catheterization Approach Offers New Hope
ATLANTA, GA, March 24, 2010 – Atlanta Catheter Therapies, Inc. (ACT) has successfully completed the prototyping phase for an innovative medical device that integrates agent delivery with vascular catheterization. ACT is focused on developing innovative catheter technologies targeting vascular disease and restenosis.
Innovative Vascular Device Offers New Hope.pdf
click to download
Start-up Veteran Joins Atlanta Catheter Therapies
Paul Fitzpatrick Excels with Early Stage Medical Device Companies
ATLANTA, GA, March 2, 2010 – Paul J. Fitzpatrick has joined Atlanta Catheter Therapies, Inc. (ACT) as Chief Executive Officer. The experienced start-up expert will guide the company through development and commercialization of innovative catheter technologies for the treatment of vascular disease and restenosis.
Fitzpatrick Joins ACT.pdf
click to download