Performance Medical Technologies

Fitta attività di #ConfapiFVG per l’incoming della Delegazione dalla Virginia (USA) organizzato dalla Regione Autonoma Friuli Venezia Giulia tramite l’Agenzia Lavoro & SviluppoImpresa e Select Friuli Venezia Giulia. Incontri istituzionali con il Presidente Fedriga e il Console USA a Milano Douglass Benning, dinner reception a Fondazione Villa Russiz in collaborazione con Confindustria Alto Adriatico, e proficui incontri B2B per le nostre Imprese associate! U.S. Consulate General Milan Lydia Alessio - Vernì Giulio Ambrosi Cinzia Sut Giulia Notaristefano Virginia SBDC Aaron Miller Chris Van Orden Fairfax City Economic Development SiteTrax.io Michele Feletig Federica Vidoni Giuliano Russo INFORMEST Consulting S.r.l. Giovanni Gracco IC&Partners EUROCABLAGGI S.R.L. Roberto Floreano Tara Gupta Map Collective Icarus Medical Innovations Tom Plutt Nader Saanouni Performance Medical Technologies Kurt Wassenaar Evan Eckersley Dave Johnson Layla Burford Keely Barton, MS Marie Spittell Christopher Bruno ENSCO, Inc. PORZIO S.R.L. Francesco Segatti

A year's worth of work recently culminated with a successful trade mission to Italy's Friuli Venezia Giulia Region. Chris Van Orden and myself at the Virginia SBDC could not have asked for a better partner than Agenzia Lavoro & SviluppoImpresa and Select Friuli Venezia Giulia, under the leadership of Lydia Alessio - Vernì. She and her team rolled out the red carpet and made sure that our five Virginia companies Map Collective, Icarus Medical Innovations, ENSCO, Inc., Performance Medical Technologies, SiteTrax.io, and Fairfax City Economic Development had top notch meetings and incredible site visits. We are already seeing a year's worth of work start to pay off with new partnerships, and potential sales and investments taking place. So many opportunities were seeded and we're excited to build on this success. Thank you also to the team at FVG especially Giulio Ambrosi, Mina Barletta, Federica Santoro, Giulia Notaristefano, Renato Farfoglia, Federica Marchesich, and Cinzia Sut who set a new standard for business assistance. It was also particularly important to have the high-level support of the U.S. Consulate General Milan and Caroline (You Kyung) Chung, and their distinguished Consul General, Douglass Benning. We look forward to welcoming the President of the Region of Friuli Venezia Giulia?Massimiliano?Fedriga and his delegation later this month to Virginia and Washington D.C. Of course, none of this would have been worth it without the dedication, entrepreneurial spirit, and innovative ideas that our companies are bringing to the market. Thank you Tara Gupta, Kurt Wassenaar and Harper Thomas, Dave Johnson Layla Burford and Haley Barefoot, Tom Plutt and Nader Saanouni, and Christopher Machut and Oleksandr Zadorozhnyi ????. as well as the partnership we have with the City of Fairfax Christopher Bruno and Marie Spittell. Thank you for the trust you put in us! While we met hundreds of people over the course of a week, we are particularly grateful for the support we received from the regions key partners including Confindustria Udine, CONFAPI FVG - Associazione Piccole e Medie Industrie del Friuli Venezia Giulia, Confindustria Alto Adriatico, PromoTurismoFVG and Mara Micolino, TEC4I FVG, and the Port of Trieste, FINCANTIERI, illycaffè, among many others. We look forward to deepening the partnership with our friends in Friuli Venezia Giulia and bringing more opportunities to our firms on both sides of the Atlantic.

We recently sat down with Harper Thomas and Kurt Wassenaar of Performance Medical Technologies to spotlight the regulatory consulting and support we've been providing for the development of an innovative NAD+ therapy aimed at treating early-stage Parkinson's disease. It's a prime example of how the right consultants can deliver immense value in helping navigate the complexities of the regulatory landscape. This spotlight not only showcases the impressive strides Performance MedTech is making around a challenging disease state but also underscores the importance of expert regulatory guidance in bringing innovative treatments to market. Here's a quick breakdown: Performance MedTech is at the forefront of clinical data science and drug development, focusing on creating therapies for early-stage Parkinson's disease using intravenous NAD+ (Nicotinamide Adenine Dinucleotide) therapy. NAD+ is a critical coenzyme whose production declines with age, leading to various health issues. Objectives ——— Our collaboration aimed to achieve the following: 1/ Create and validate an intravenous NAD+ therapy for early-stage Parkinson's disease. 2/ Design and implement clinical trials that meet stringent FDA regulatory requirements. 3/ Develop a sophisticated bioinformatics system to organize clinical data, ensure HIPAA compliance, and support clinical trial design. The project presented several challenges, including validating anecdotal evidence of NAD+ therapy's effectiveness through structured scientific methods and clinical trials; navigating complex FDA processes, and managing the costs and resource demands. Approach ——— 1/ We provided expert guidance on FDA requirements, helping PMT design clinical trials that meet regulatory standards. 2/ PMT developed an advanced bioinformatics system incorporating AI for pattern analysis, ensuring effective data management and HIPAA compliance. 3/ Together, we developed a compliant clinical trial framework, focusing on creating an approved NAD+ API and protocol. By centralizing resources and expertise, we quickly provided the right consultants and support — avoiding the costly and time-consuming process of finding and validating experts. Future Directions ——— Looking ahead, PMT is exploring: ??Developing technologies for the early diagnosis of Parkinson's disease, aiming to intervene at the earliest stages. ? Extending the potential benefits of NAD+ therapy to other neurodegenerative diseases such as Alzheimer's and dementia. ——— Talk to us when you need a consulting and resourcing support partner whose commitment to quality, integrity, and long-term value reflects your own.

Thank you to Regional Accelerator and Mentoring Program and VIPC | Virginia Innovation Partnership Corporation for this amazing opportunity. Congratulations to all companies in the cohort and we are excited for what lies ahead for PMT! Keely Barton Kurt Wassenaar Serena Satcher, MD, FAAPMR, IFM-CP Su Fairchild