NEWS

Bearpac Medical announces CE Mark Certification for the Passio™ Pump Drainage System

Moultonborough, N.H., April 5, 2022 – Bearpac Medical, LLC is pleased to announce that it has received CE Mark certification for use of the Passio Pump Drainage System with indications for the intermittent drainage of recurrent and symptomatic pleural effusions and malignant ascites.

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusions and malignant ascites. The Passio pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag. The Passio catheter is exclusively designed for use with the Passio collection system. Passio provides flow control throughout the therapy at lower vacuum pressures than competitive devices on the market today.

“As Bearpac builds on our product offering, the CE Mark for the Passio system is another important milestone. This new indication and expansion to CE provides Bearpac with an opportunity to now introduce Passio to patients and physicians around the globe,” said Jay Zimmerman, President of Bearpac Medical.

The CE Mark confirms that Passio meets quality standards for design, manufacture and final inspection. The certification enables Bearpac Medical to market Passio in European Economic Area (EEA) member countries as the company explores expansion opportunities in Europe as part of its global strategy.

About Bearpac Medical, LLC

Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions. For more information, please visit www.bearpac.com.

Bearpac Medical Receives Innovative Technology Contract from Vizient For the Passio™ Pump Drainage System - Contract awarded for products that bring improvement to health care industry

Moultonborough, N.H., March 15, 2022 – Bearpac Medical, LLC announced that its Passio Pump Drainage System has received an Innovative Technology contract from Vizient, Inc. the nation’s largest member-driven health care performance improvement company. The contract was awarded based on the recommendation of the Passio Pump Drainage System by hospital experts who serve on one of Vizient’s member-led councils, and it signifies to Vizient members unique qualities that potentially bring improvement to the health care industry.

Innovative Technology contracts are recommended after review and interaction with products submitted through Vizient’s Innovative Technology Program. Vizient member-led councils identify technologies that have the potential to enhance clinical care, patient safety, health care worker safety or improve business operations of health care organizations.

Bearpac has developed a digital handheld control unit with a pump system that evacuates patient fluid into a collection bag using between -45 and -70 cm H2O of vacuum pressure, an exponentially lower vacuum level when compared to the competition. Passio’s convenient digital platform was designed to be intuitive, providing malignant pleural effusion (MPE) patients and caregivers with the confidence to control their therapy in the comfort of their own homes.

“Bearpac is excited and honored to be recognized by Vizient for the innovation that Passio brings to the MPE drainage space which has not evolved in over 20 years,” said Jay Zimmerman, President of Bearpac Medical.  “We look forward to working with Vizient to offer their members the next generation of pleural drainage therapy.”

“Our member councils reviewed and determined the Passio Pump Drainage System should be recognized with an Innovative Technology contract based on its potential to make an incremental difference in health care,” said Kelly Flaharty, director of contract process. “Congratulations to Bearpac on receiving this contract status.”

Vizient represents a diverse membership base that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers and represents more than $110 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to evaluate products for their potential to bring real innovation to health care. Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle.

About Bearpac Medical, LLC

Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions. For more information, please visit www.bearpac.com.

Bearpac Medical Selected to Exhibit the Passio™ Pump Drainage System at Vizient Innovative Technology Exchange

Moultonborough, N.H., August 17, 2021 – Bearpac Medical, LLC has been selected to exhibit the Passio Pump Drainage System for the drainage of recurrent and symptomatic pleural effusions at the Vizient Innovative Technology Exchange. Vizient, Inc, the nation’s largest member-driven health care performance improvement company, will hold the Exchange virtually Sept. 21-23.

The annual Innovative Technology Exchange offers selected suppliers the unique opportunity to demonstrate their technologies to supply chain and clinical leaders from Vizient’s member hospitals and subject matter experts who serve on their supply councils. Each technology will showcase how it improves clinical outcomes, enhances safety or drives incremental improvements to health care delivery or business models.

Bearpac Medical has entered the market for malignant pleural effusion drainage, which has not evolved in 20+ years. The Passio Pump Drainage System incorporates technology in order to provide control over the patient’s drainage therapy. Bearpac has developed a digital handheld control unit with a pump system that evacuates patient fluid into a collection bag using between -45 and -70 cm H2O of vacuum pressure, an exponentially lower vacuum level when compared to the competition. The Passio system offers superior clinical and technological benefits over the outmoded products currently on the market.

“Passio was designed to be intuitive, providing MPE patients with the confidence to control their therapy in the comfort of their own homes. We have seen patients quickly embracing our convenient digital platform which differentiates Passio from all other products on the market,” said Jay Zimmerman, President of Bearpac Medical.

“As a startup, we are honored to be included among the select group of suppliers invited to the Vizient Innovative Technology Exchange to showcase the Passio Pump Drainage System and are very excited to demonstrate our novel device to the Vizient member hospitals. Bearpac’s goal is to improve patient care for those affected by malignant pleural effusions.”

“Suppliers come to the Exchange hoping to be awarded an Innovative Technology contract, which signals health care providers of their product’s unique qualities,” said Debbie Archer, procurement compliance director, Vizient. “We are pleased to include this technology in the group selected to participate.”

The annual Innovative Technology Exchange is part of Vizient’s Innovative Technology Program that includes product review of supplier-submitted technologies by member-led councils and task forces. Since 2003, Vizient has received over 2,800 technology submissions as part of its Innovative Technology Program.

Bearpac Medical Announces New Home Use Indication for the Passio™ Pump Drainage System

Moultonborough, N.H., December 1, 2020 – Bearpac Medical, LLC is pleased to announce that the FDA has granted 510(k) clearance for the Passio Pump Drainage System for the additional indication of home use to provide therapy for malignant and other recurrent pleural effusions.

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion. The Passio pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag. The Passio catheter is exclusively designed for use with the Passio collection system. Passio provides flow control throughout the therapy at lower vacuum pressures than competitive devices on the market today.

“As Bearpac builds on our product offering, we are excited to add the home use indication to our pleural indication. Passio, designed to be intuitive, provides patients with the confidence to control their therapy in the comfort of their own homes. We have seen patients quickly embracing our convenient digital platform which differentiates Passio from all other products on the market,” said Jay Zimmerman, President of Bearpac Medical.

About Bearpac Medical, LLC

Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions. For more information, please visit www.bearpac.com.

Bearpac Medical announces commercial launch of the new Passio™ Pump Drainage System after receiving FDA 510(k) Clearance

Moultonborough, N.H., August 26, 2020 – Bearpac Medical, LLC is pleased to announce that they have launched a new FDA 510(k) cleared device intended to treat patients with malignant and other recurrent pleural effusions.

For the first time, a Class II electronic handheld pump will be available to clinicians for a more controlled delivery of therapy for patients experiencing pleural effusions.

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion. The Passio pump is attached to an implanted Passio catheter using the disposable collection kit and is activated to begin the evacuation of fluid into the collection bag. The Passio catheter is exclusively designed for use with the Passio collection system. Passio provides electronic flow control throughout the therapy at lower vacuum pressures than competitive devices on the market today.

“Pleural effusion drainage devices haven’t changed in decades. Bearpac’s strategy of combining technology with a user friendly design allow the caregiver and/or patient the ultimate control over the therapy. Our ultimate goal is to make this stage of their treatment less painful,” said Jay Zimmerman, President of Bearpac Medical.

About Bearpac Medical, LLC

Bearpac Medical is a privately held medical technology company headquartered in New Hampshire, focused on the development of novel thoracic drainage products to improve the lives of patients experiencing pleural effusions. For more information, please visit www.bearpac.com.