Leading innovation in MedTech

T45 Labs is a specialized medical technology innovation company located in Santa Clara, Silicon Valley, California.

We focus on the development of innovative medical technologies that address unmet clinical needs or seek to improve the current standard of care.

Leading innovation in MedTech

T45 Labs is a specialized medical technology innovation company located in Santa Clara, Silicon Valley, California.

We focus on the development of innovative medical technologies that address unmet clinical needs or seek to improve the current standard of care.

VISION

We aim to discover and develop innovative products for the betterment of human care.

Our goal is to build technology companies that create a positive impact in the medical sector and bring life-enhancing innovations to market.

VISION

We aim to discover and develop innovative products for the betterment of human care.

Our goal is to build technology companies that create a positive impact in the medical sector and bring life-enhancing innovations to market.

OUR PROCESS

OUR PROCESS

Innovation does not come easily in the medical device industry. Developing a product is expensive, time-consuming, and extremely risky, so experience, careful planning, and adapting to changes in market dynamics are all essential for success.

While our rigorous idea evaluation process allows our teams to focus on the most critical unmet clinical needs, our structure, resources, and processes will enable them to turn promising projects into breakthrough medical technology rapidly.

Anticipate

Adapt

Execute

Coming up with the right MedTech concept means doing the right thing, at the right time, and with the right approach.

These are the key steps we follow:

1. Ideation

Verify a concept against current market dynamics before taking it to investors. Discuss it thoroughly with doctors and key opinion leaders.

2. Evaluation

Vet the concepts with clinical champions. Finding good clinicians to weigh in on the R&D is the first step.

3. Seed Funding

Innovative solutions that promise an exciting business opportunity will receive seed funding to support the company and its clinical needs.

4. Prototype development

Use all the R&D information to turn an idea into an engineering specification, a model, and a working prototype.

5. Clinical & Regulatory

A solid regulatory backbone is critical for new MedTech applications. Determine how likely a product is to be approved using the best possible estimation from regulatory experts.

6. External funding

Consider scalability aspects early in the development process to ensure that the devices have the best features to attract external investors.

7. Exit strategy

Keep the companies’ momentum going, attack and resolve problems in the marketplace, and create a well-defined story before leading towards a successful exit.

STRATEGY

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Targeted early-stage medical device/technology companies and assets exclusively focused in the cardiovascular space.

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Focused on large unmet or inadequately met clinical segments which provide for a significant addressable market, both in terms of medical procedures and dollars.

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Combination of large addressable markets and minimal costs to get there results in significant financial returns.

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Gain sponsorship/support from relevant prominent physicians in conjunction with establishing the technology to ensure that the opportunity is real – avoid “if you build it, they will come” mentality.

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Fast Follower Strategy – not trying to “reinvent the wheel” but rather to identify segments where an existing company has done groundwork to identify a clear clinical need, educated clinicians & regulatory authorities.

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Leverage the established market foundation to introduce superior technology to address the clinical need.

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Establish early dialogue and interest of relevant large strategic companies and solicit early input from them with respect to product and market development as they will be acquirors of the technology/company

Exceptional leadership with a proven track record in strategic and tactical execution

Marwan Berrada-Sounni

Founder and Chief Executive Officer

Marwan has a stellar record of leading and developing medical device businesses for over 20 years.

Marwan was Sr. Director of Product Development at the Cleveland Clinic Foundation, where he was also part of the commercialization funding committee for the Global Cardiovascular Innovation Center. Marwan held various technical/engineering, managerial, and executive positions in MedTech companies.

An inventor at heart, Marwan works closely with R&D teams and has been a part of several first-generation medical device product launches. He is genuinely passionate about empowering the people around him and driving global medical innovation.

Currently, he holds 14 medical device patents and an additional 12 patent applications. Marwan has a bachelor’s and master’s degree in Mechanical Engineering from the University of Minnesota and an MBA in Finance from McGill University.

PORTFOLIO

Current Portfolio Companies:

T45 Labs is currently nurturing several companies in various phases of development from early stage concepts to next generation work and path to commercialization.

Advanced NanoTherapies
Next-Generation Drug-Coated Balloons

Advanced NanoTherapies (A.N.T.) was established in 2019 when it secured an exclusive worldwide license with the Cleveland Clinic for its proprietary nanoparticle technology.

A.N.T. is a novel, next-generation drug delivery platform which addresses a significant clinical medical need in the vascular space. A.N.T. aims to disrupt the DCB field with a therapeutic option to safely and effectively treat peripheral artery disease, coronary in-stent restenosis, and small vessel de-novo lesions using a dual-drug approach.

VahatiCor
An Option for “no-Option” Patients

VahatiCor alleviates the angina burden for patients who have exhausted current medical therapies and wish to improve their heart micro-perfusion through smart implantable flow reduction devices.

VahatiCor is developing the next-generation device by addressing the current clinical and technical limitations of its main competitor, NeoVasc.

NuevoSono
The Clear IVUS Choice

NuevoSono’s technology provides near OCT resolution with imaging depth and convenience of IVUS. There is no need for contrast injection to visualize a clear coronary and peripheral anatomy (i.e., intima, media, & adventitia).

The company has acquired rights to an imaging technology from Cleveland Clinic and has assembled an executive and R&D team; currently recruiting SAB Members. NuevoSono is seeking an exclusive Joint Development Agreement (Shared-Risk/Shared-Reward), including developing an A.I. technology platform.

ReCava
A Novel Take on Congestive Heart Failure

Congestive heart failure (HF) is a growing epidemiologic problem and a significant source of morbidity, mortality, and health care expenditure. Approximately 5.1 million people in the United States carry a diagnosis of HF, and the prevalence continues to rise. Acute decompensated heart failure (ADHF) is a clinical syndrome of worsening signs and symptoms of HF that often leads to hospitalization or an emergency department visit. Almost 33% of patients hospitalized are re-hospitalized within 60 to 90 days of discharge, and nearly 66% die or will be re-hospitalized within one year. The pathophysiology of fluid retention in ADHF is linked to managing heart pre-load on the right side of the heart and the pressure difference in the kidney between the arterial and venous sides.

ReCava is a fast follower of two companies combining two devices into one. Intellectual Property is assessed and developed to ensure a clear path is discovered and secured.

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