Category: Uncategorized

BROOMFIELD, Colo. – October 28, 2016 – Colorado Therapeutics LLC, a privately held medical device company with a proprietary technology platform for the production of innovative cross-linked tissue products, announced today that it has entered into a worldwide exclusive license agreement with Micro Interventional Devices, Inc. (MID), a leader in minimally invasive and catheter-based compliant fixation technology. Under this agreement, Colorado Therapeutics will gain rights to MID’s proprietary PolyCor™ compliant soft tissue anchoring technology, which provides an adjunct or alternative to standard suture. Colorado Therapeutics and Micro Interventional Devices will initially work together to design and develop a minimally invasive laparoscopic hernia anchoring device for securing Colorado Therapeutics’ recently FDA-cleared novel xenogenic biologic tissue matrix for hernia repair, and subsequently for venous valve implantation applications.

“Combining MID’s minimally invasive anchor technology with our novel xenogenic biologic tissue product will allow us to provide surgeons with a unique biologic tissue matrix that can be secured in a minimally invasive manner, potentially reducing procedural times and improving patient outcomes,” said Joseph B. Horn, Colorado Therapeutics’ president and CEO. “Moreover, this partnership exemplifies our vision to become a fully integrated commercial company, providing a suite of patient solutions to address a broad range of products including soft tissue reinforcement, regenerative, and vascular applications.”

“Partnering with Colorado Therapeutics expands the use of our PolyCor™ anchor technology to applications beyond our current focus in structural heart repair,” said Michael Whitman, Micro Interventional Devices’ president and CEO. “The combination of Colorado Therapeutics’ unique tissue matrix together with our proprietary PolyCor™ anchor technology will provide a durable and compliant minimally invasive solution for laparoscopic hernia repair.

Colorado Therapeutics received U.S. FDA 510(k) clearance for its novel xenogenic biologic tissue matrix in October 2016. Earlier in the year, MID received FDA clearance for the use of their PolyCor™ soft tissue anchors for transapical access and closure with their Permaseal™ device.

Financial details of the license agreement are not being disclosed.

About Hernia Repairs
A hernia occurs when an organ, intestine or fatty tissue is pushed through a hole or a weak spot in the surrounding muscle or connective tissue. More than one million hernia repairs are performed each year in the U.S. Hernias have a high rate of recurrence, and surgeons often use a biologic or synthetic tissue, or mesh, to strengthen the weakened or damaged tissue, and reduce the rate of recurrence.¹

About Colorado Therapeutics
The Company’s proprietary platform produces extremely strong, durable, and biocompatible tissue from xenogenic sources using innovative cross-linked tissue processing technology. Resulting tissue products demonstrate superior benefits compared to currently available biologic or synthetic products. Colorado Therapeutics is developing products for multiple indications to target the $2.25 Billion U.S. soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, orthopedic, and other applications that can benefit from the company’s proprietary technology. Colorado Therapeutics’ novel xenogenic biologic tissue matrix received U.S. FDA 510(k) clearance in 2016 for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.

Colorado Therapeutics corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

About Micro Interventional Devices, Inc. (MID)
MID designs, develops and manufactures minimally invasive and catheter-based technologies that address unmet needs in cardiac surgery and interventional cardiology. MID’s proprietary PolyCor™ anchors form the basis of the technology platform that consists of ultra low mass, biocompatible implantable devices that are synergistic with natural cardiac function. For more information on MID’s proprietary PolyCor anchors and technology, please visit the Micro Interventional Devices website at www.microinterventional.com.

Corporate and Media Contacts: 
Valerie Ray, Chief Operating Officer
Colorado Therapeutics LLC
Telephone: (303) 469-9459
vray@co-therapeutics.com 

Aline Sherwood
Scienta Communications
Telephone: (312) 238-8957
asherwood@scientapr.com

Katherine Whitman, Product Director
Micro Interventional Devices, Inc.
Telephone: (215) 600-1270
info@microinterventinoal.com

Note for editors: the Colorado Therapeutics/MID PolyCor™ anchor technology for hernia repair or venous valve implantation has not been cleared by the FDA and is not currently available for commercial sale in any jurisdiction.

¹U.S. Food and Drug Administration (Updated 11/16/2012). Hernia Surgical Mesh Implants.

– Series A Financing will be Opened to Support Commercial Launch –

BROOMFIELD, CO – October 21, 2016 – Colorado Therapeutics LLC, a privately held medical device company with a proprietary technology platform for the production of innovative cross-linked tissue products, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for a novel xenogenic biologic tissue matrix. The Colorado Therapeutics xenograft implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. This unique xenograft product has been developed to combine the benefits of currently available biologic and synthetic products while being packaged in a dry state, making it a ready-for-use, off-the-shelf, biologic tissue matrix. Colorado Therapeutics, now with 510(k) FDA clearance, has the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.

“Receiving 510(k) clearance from the U.S. FDA is very exciting,” commented Joseph B. Horn, Colorado Therapeutics president and chief executive officer. “Over the coming months, the Company will be preparing for a U.S. commercial launch in the surgical repair of damaged or ruptured soft tissue membranes such as the repair of hernia defects.”

Colorado Therapeutics has also announced it will open a Series A financing to accelerate corporate activities for the U.S. commercial launch. The proceeds of the Series A financing will also advance further development of the Colorado Therapeutics product pipeline that utilizes the Company’s innovative and proprietary tissue processing technology.

Mr. Horn continued, “The receipt of this 510(k) clearance is a significant milestone for Colorado Therapeutics and will be a spring board for advancing the Company’s product pipeline, which includes other soft tissue repair opportunities such as dura repair, skin substitutes, covered stents for peripheral vascular disease, and vascular grafts.”

For more information on the Colorado Therapeutics differentiated innovative and proprietary crosslinked tissue processing technology and product pipeline, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

About Hernia Repairs
A hernia occurs when an organ, intestine or fatty tissue is pushed through a hole or a weak spot in the surrounding muscle or connective tissue. More than one million hernia repairs are performed each year in the U.S. Hernias have a high rate of recurrence, and surgeons often use a biologic or synthetic tissue, or mesh, to strengthen the weakened or damaged tissue, and reduce the rate of recurrence.¹

About Colorado Therapeutics
The Company’s proprietary platform produces extremely strong, durable, and biocompatible tissue from xenogenic sources using innovative cross-linked tissue processing technology. Resulting tissue products demonstrate superior benefits compared to currently available biologic or synthetic products. Colorado Therapeutics is developing products for multiple indications to target the $2.25 Billion U.S. soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, orthopedic, and other applications that can benefit from the company’s proprietary technology. Colorado Therapeutics corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

Corporate and Media Contact: 
Eric Schauble, Vice President
Colorado Therapeutics LLC
Telephone: (303) 469-9459
eschauble@co-therapeutics.com 

Aline Sherwood
Scienta Communications
Telephone: (312) 238-8957
asherwood@scientapr.com

¹U.S. Food and Drug Administration (Updated 11/16/2012). Hernia Surgical Mesh Implants.

– Colorado Therapeutics Closes Angel Financing Round and Will Open Series A Financing in Support of Anticipated Commercial Launch –

BROOMFIELD, CO – January 28, 2016 – Colorado Therapeutics LLC, a privately held medical device company that is leveraging over 15 years of innovative and proprietary cross-linked tissue processing technology, announced today that it has submitted a 510(k) application requesting clearance of a novel xenogenic biologic tissue matrix, with the U.S. Food and Drug Administration (“FDA”) to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes including the repair of hernia defects. This unique product has been developed to combine the benefits of currently available biologic and synthetic products while being packaged in a dry state requiring no preparation or rehydration, making it a ready-for-use, off-the-shelf, biologic tissue matrix.

Pursuant to Section 510(k), the FDA has 90 days in which to clear a Class II medical device for commercial distribution or to seek additional information. Following notification of FDA clearance, Colorado Therapeutics would immediately have the right to commence manufacturing, marketing and sales of the product in the United States and its possessions subject to FDA jurisdiction.

Colorado Therapeutics has also announced the closing of an Angel Financing, proceeds from which have been used to prepare the 510(k) filling. Colorado Therapeutics will be opening a Series A financing round shortly to prepare the Company for commercial launch of this novel and unique xenograft implant for soft tissue repair, should it be cleared by the FDA.

About Hernia Repairs
A hernia occurs when an organ, intestine or fatty tissue is pushed through a hole or a weak spot in the surrounding muscle or connective tissue. More than one million hernia repairs are performed each year in the U.S. Hernias have a high rate of recurrence, and surgeons often use a biologic or synthetic tissue, or mesh, to strengthen the weakened or damaged tissue, and reduce the rate of recurrence.

About Colorado Therapeutics
The Company’s proprietary cross linked tissue processing technology produces extremely strong, durable, and biocompatible tissue from xenogenic sources that demonstrate superior benefits compared to currently available biologic or synthetic products. Colorado Therapeutics is developing products for multiple indications to target the $2.25 Billion U.S. soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, orthopedic, and other applications that can benefit from the company’s proprietary technology. Colorado Therapeutics corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For Broomfield, CO USA | Phone 303.469.9549 | Email info@co-therapeutics.com more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

Corporate and Media Contact:
Eric Schauble, Vice President
Colorado Therapeutics LLC
Telephone: (303) 469-9459
eschauble@co-therapeutics.com

Aline Sherwood
Scienta Communications
Telephone: (312) 238-8957
asherwood@scientapr.com

Note for editors: the Colorado Therapeutics xenograft implant has not been cleared by the FDA and is not currently available for commercial sale in any jurisdiction.

BROOMFIELD, CO – April 20, 2015 – Colorado Therapeutics, LLC, a privately held emerging medical device company, has been created to leverage over 15 years of innovative and proprietary tissue processing technology. The Company has developed innovative and disruptive xenogenic (sourced from different mammalian species) biologic tissue matrix products for a broad range of soft tissue reinforcement, regenerative, and vascular applications. To provide more information on the company, technology, and products in development, the company has launched a new website.

The Company’s proprietary cross linked tissue processing technology produces extremely strong, durable, and biocompatible tissue from xenogenic sources that demonstrate superior benefits compared to currently available biologic or synthetic products. Colorado Therapeutics is developing products for multiple indications to target the $2.25 Billion U.S. soft tissue reinforcement and regeneration markets. Products in development include abdominal wall reconstruction, orthopedic, and other applications that can benefit from the company’s proprietary technology.

Colorado Therapeutics corporate headquarters and pre-commercialization facilities are located in Broomfield, Colorado. For more information on Colorado Therapeutics technology and career opportunities, please visit the Colorado Therapeutics website at www.co-therapeutics.com.

Corporate and Media Relations Contact:
Telephone: (303) 469-9459
info@co-therapeutics.com