Press Releases

N Brereton Medical Technologies Receives Positive FDA Response for FenBlock Submission

FOR IMMEDIATE RELEASE

N Brereton Medical Technologies Receives Positive FDA Response for FenBlock Submission

[Lynchburg, VA] — December 26, 2024 — N Brereton Medical Technologies is pleased to announce

that the U.S. Food and Drug Administration (FDA) has provided a welcoming and highly positive

response to our recent letter of submission for FenBlock, prepared by the Health Science experts at

Kymanox, Inc.

In their review, the FDA confirmed that the revised intended use and indications for use statements for

FenBlock are consistent with the labeling of fentanyl products and do not present an Outstanding Drug

Issue (ODI). This affirmation marks a significant step forward in the development of FenBlock,

underscoring its alignment with established standards for opioid titration devices.

The response further validates the appropriateness of FenBlock’s new proposed indication for use in

cancer patients, reflecting FDA’s recognition of the device’s potential to address critical needs in pain

management and dependency treatment.

“This positive feedback from the FDA is an important milestone for N Brereton Medical Technologies

and demonstrates our commitment to aligning FenBlock with the highest regulatory and clinical

standards,” said Neil Brereton Jackson, CEO of N Brereton Medical Technologies. “We are confident

that FenBlock will serve as a transformative solution for patients and healthcare providers, offering a

safer and more precise method of medication titration.”

N Brereton Medical Technologies remains dedicated to advancing the commercialization of FenBlock

and addressing the global challenges of opioid dependency and pain management.

About FenBlock

FenBlock is an innovative drug dose management device designed to support the precise titration of

fentanyl and other medications. With its focus on safety and efficacy, FenBlock aims to provide patients

and healthcare providers with an off-ramp from dependency, enabling more controlled and

individualized care with support of their care provider.

About N Brereton Medical Technologies

N Brereton Medical Technologies is committed to developing groundbreaking solutions that improve

patient outcomes and redefine care delivery. Through innovation and collaboration, the company is

tackling some of the most pressing challenges in healthcare, including Optimal Dependency

Management (ODM) for opioid dependency and pain management.

Major General, U.S. Army, Retired Bob Dees Joins N Brereton Medical Technologies

Exciting Announcement:
Major General, U.S. Army, Retired
President, National Center for Healthy Veterans [www.healthyveterans.org]
Author, The Resilience Trilogy,
Joins N Brereton Medical Technologies Board of Advisors as Strategic Advisor; United States Military Support

N Brereton Medical Technologies is honored to announce that General Bob Dees, President of the National Center for Healthy Veterans, has joined our Board of Advisors. A distinguished leader with a lifetime of service in the United States Army, General Dees brings unparalleled awareness and passion to our mission of revolutionizing the fight against addiction to bring an off-ramp to drug use within the military and throughout the nation.

General Dees, renowned for his commitment to the well-being of veterans and communities, has been instrumental in shaping initiatives that empower individuals to reclaim their health and purpose. His leadership at the National Center for Healthy Veterans reflects his unwavering dedication to human dignity and freedom—a mission that resonates deeply with our company’s vision.

In his new role, General Dees will lend his strategic insight and leadership to advance the development and military patient use of FenBlock, N Brereton’s groundbreaking solution for those seeking or through their physician’s encouragement to safely recapture their health from fentanyl and opioid dependence and use. FenBlock’s patented graduated titration technology awaiting FDA (pre-clinical) clearance offers a needed structured, safer path to sobriety—marking as Gen. Dees states; “a monumental contribution to humankind.”

“FenBlock embodies hope, healing, and renewal,” says General Dees. “The technology represents a bold, unprecedented step toward liberation from the chains of opioid addiction. I am honored to support this inspiring mission, knowing the transformative impact it will have for countless individuals and families.”

This partnership aligns with General Dees’ lifelong work—restoring lives, fostering community, and helping people find lasting freedom. Together, N Brereton Medical Technologies and General Dees aim to pave the way for a new chapter in the military’s fight against addiction, offering a beacon of hope to veterans and all those battling substance dependence.

With General Bob Dees on board, N Brereton Medical Technologies is poised to amplify its impact, delivering life-changing solutions for those in need. The inspiring story of FenBlock is just beginning—and with leaders like General Dees alongside us, the future looks brighter than ever. Contact neil@FenBlockmed.com for further information.

N Brereton Medical Technologies Joins the Parenteral Drug Association (PDA)

N Brereton Medical Technologies Joins the Parenteral Drug Association (PDA) to Drive Innovation and Patient-Centered Solutions

N Brereton Medical Technologies is proud to announce our membership in the Parenteral Drug Association (PDA), www.pda.org the leading global provider of science, technology, and regulatory information. This partnership aligns with our mission to ensure that FenBlock—a combination novel medical device—is developed, cleared by the FDA, and prescribed with a commitment to best practices, innovation, and safe patient-centered solutions.

Our Commitment through PDA Membership

Through every stage of FenBlock’s design, from innovation to patient use, N Brereton Medical Technologies is guided by the principles of scientific excellence and regulatory rigor. Our partnership with PDA reflects our dedication to embedding the highest standards into FenBlock’s development, ensuring it provides safe, effective, and innovative solutions to help patients overcome fentanyl addiction.

About PDA

For 65 years, the PDA has been a trusted global leader in advancing science, technology, and regulation within the pharmaceutical and biopharmaceutical industries. PDA brings together technical experts, manufacturers, regulatory officials, and academic leaders to foster collaboration and knowledge sharing. Their mission is to develop scientifically sound, practical technical information to guide the future of pharmaceutical products and manufacturing science.

PDA’s Mission and Vision

Mission: To provide scientifically sound, practical technical information and resources that advance science and regulation for the pharmaceutical and biopharmaceutical industries through the expertise of its global membership.

Vision: To be the foremost global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical industry.

With over 10,500 individual members worldwide, PDA draws on the expertise of its members to influence industry practices, shaping the future of pharmaceutical technology through high-quality technical reports, conferences, and education. PDA’s efforts enable members to better serve patients through innovation and effective regulation.

N Brereton Medical Technologies’ Mission

At N Brereton Medical Technologies, we are committed to advancing pharmaceutical and biopharmaceutical science and regulation, ensuring that our products—such as FenBlock—reflect the latest industry standards and serve the best interests of patients. Our collaboration with PDA reinforces our mission to deliver innovative, safe, and patient-centered solutions at every step, from design to prescribed use.

We look forward to working closely with PDA’s network of experts, leveraging technical knowledge and regulatory insights to bring FenBlock to market and make a meaningful impact in the lives of patients battling fentanyl addiction.

N Brereton Medical Technologies Partners with Kymanox

N Brereton Medical Technologies Partners with Kymanox to Accelerate Development

and Commercialization of FenBlock

Forest, Virginia – March 1, 2024 – N Brereton Medical Technologies, a pioneering

company in health and wellness innovation, is thrilled to announce a strategic

partnership with Kymanox, a leading life science solutions partner headquartered in

Raleigh, North Carolina.

Kymanox brings to the table a diverse team of experts with a deep understanding of

the life sciences industry. With their unparalleled expertise and track record of success,

Kymanox is well-equipped to support N Brereton Medical Technologies in accelerating

the development, FDA clearance, and commercialization of FenBlock, a

groundbreaking medical device designed to combat the fentanyl and opioid epidemic.

"FenBlock represents a crucial advancement in addiction treatment, and we are

excited to partner with Kymanox to bring this innovative solution to market," said Neil

B. Jackson, Founder and CEO of N Brereton Medical Technologies. "Kymanox's

commitment to excellence and their proven track record make them the ideal partner

to help us navigate the complexities of the regulatory landscape and accelerate the

development and commercialization of FenBlock.”

Kymanox's Global Headquarters, located in Raleigh | Durham | RTP, NC, and

Morrisville, North Carolina, provide the perfect strategic base for collaboration between

the two companies. With access to top-tier talent and state-of-the-art facilities,

Kymanox is well-positioned to support N Brereton Medical Technologies throughout

the development process.

"We are thrilled to partner with N Brereton Medical Technologies to support the

development and commercialization of FenBlock," said Stephen Perry, Founder and

CEO of Kymanox. "At Kymanox, we pride ourselves on our ability to connect the dots

and provide end-to-end solutions that drive success. Together with N Brereton Medical

Technologies, we look forward to making a meaningful impact in the fight against the

fentanyl and opioid epidemic.”

About N Brereton Medical Technologies:

N Brereton Medical Technologies is a leading innovator in health and wellness,

dedicated to developing groundbreaking solutions to address fentanyl and opioid

healthcare challenges. With a focus on empowering patients and transforming lives, N

Brereton Medical Technologies is committed to driving positive change in the

healthcare industry.

About Kymanox:

Kymanox is a premier life science solutions partner, offering a comprehensive suite of

services to support the development, regulatory approval, and commercialization of

pharmaceuticals, biologics, medical devices, and combination products. With a team

of seasoned experts and a proven track record of success, Kymanox is trusted by

leading companies in the life sciences industry.

FENBLOCK™

PRESS RELEASES

N Brereton Medical Technologies Receives Positive FDA Response for FenBlock Submission

Major General, U.S. Army, Retired Bob Dees Joins N Brereton Medical Technologies

N Brereton Medical Technologies Joins the Parenteral Drug Association (PDA)

N Brereton Medical Technologies Partners with Kymanox

PRESS RELEASES

N Brereton Medical Technologies Receives Positive FDA Response for FenBlock Submission

Major General, U.S. Army, Retired Bob Dees Joins N Brereton Medical Technologies

N Brereton Medical Technologies Joins the Parenteral Drug Association (PDA)

N Brereton Medical Technologies Partners with Kymanox

This website uses cookies.