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Adverum Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

RA/QA and clinical services consultancy company dedicated to medical devices.
We have been providing services to a wide variety of medical devices in every Class to prepare technical documents for CE certification and FDA authorization.
Services that are sought most are
Compiling or updating Technical Files according to MDR (EU 2017/745) and IVDR (EU 2017/746)
CEP, CER, PMCF Plan, Clinical Trial Protocols
QMS updates
Sterilization Validation, Process Validation, Packaging Validation, Software Validation, etc.
GAP, Mock, Supplier Audits
Medical device registration in 140 countries

An investment group transforming

the world of healthcare one sector at a time.

We consolidate CROs and medical labs.

The United Nations called for the One Heath approach to combating pandemic threats at the 3 vectors of transmission: animals to people, people to people, and environment to people -- and vice versa.

Aequor is the only company with products that control antimicrobial-resistant (AMR) pathogens at all 3 vectors of transmission.

Twenty-five of our small molecules remove biofilm in minutes, prevent biofilm formation for days, kill AMR and multi-drug-resistant (MDR) pathogens alone and in combination with existing biocides at sub-MIC levels -- reducing the need for harmful, toxic biocides. These 25 are EPA approved and available in ton quantities. They are used in our proprietary products for environmental sanitation: surface cleaners, water treatments and industrial process enhancers (boost algae and yeast biomass by up to 40% for use in biofuels and bio-based co-products (food, feed, nutraceuticals, chemicals, plastics, materials, etc.).

Our new drug candidates are in pre-clinical Hit-to-Leas stage. They kill the latest clinical strains sent to Aequor by the NIH and CDC. The NIH awarded Aequor free pre-IND trials to develop up to 4 of them and the DOD offered the same to develop 5 of them. They are derived from a new genus and several new species of marine microbes that produce “green,” non-toxic chemicals that target Gram-negative and Gram-positive bacteria and fungi.

Our products uniquely kill bacteria and fungi at all stages of growth -- including biofilm. Biofilm is the first resistance response of microorganisms to protect themselves against environmental stresses and is associated with most infections and diseases. Removal of biofilm by surface scraping, UV, heat, biocides and antibiotics, etc. signal to the underlying microorganisms when and how fast to build a thicker biofilm shield.

The U.S. Centers for Disease Control (CDC) associate biofilm with 90% of hospital-acquired infections, such as those caused by contamination on indwelling medical devices, ventilators, and water and air systems. The CDC recently reported that 20% of U.S. COVID deaths were due to these secondary infections. Additional life-threatening infections are increasingly traced to biofilm in air and water systems in institutional and commercial buildings and homes. For example, Legionnaire’s Disease, which claimed 17 lives, was traced to biofilm in a hotel’s air conditioners that became aerosolized and inhaled. It is no coincidence that every pathogen on the CDC and WHO lists of urgent threats, pandemic threats, and bioterrorist threats is a biofilm-former. Every drug-resistant “Superbug” strain is a biofilm-former and is considered incurable. Additionally, several microbial species are captures in the same biofilm, increasing the incidence of horizontal gene transfer (Li et al., 2001; Angles et al., 1993; Dunny et al., 1995) and spawning the emergence of new antimicrobial-resistant (AMR) strains.

There are few remedies for biofilm. Physical removal (sterilization, scraping, UV) works for a short-term (e.g., biofilm was recorded on a titanium plate within 30 seconds of sterilization). Biocides (antiseptics, disinfectants, antimicrobials, and antibiotics) are designed to kill free-floating (planktonic), actively growing microorganisms, and the dose of needed to disrupt a biofilm is approximately 1000x the concentrations that are effective against planktonic bacteria (Raffa et al., 2003), which is a dose that is lethal to humans. The overuse of biocides and antibiotics has contributed to the emergence of the AMR Superbugs – and left a cumulative and persistent environmental footprint. Natural antimicrobials, such as silver and other metals, are expensive and eventually trigger the formation of thicker biofilm, resulting in the loss of efficacy over time.

If you combat biofilm at all vectors of transmission, you control AMR pandemic threats.

analytical instruments

AlephBot is developing a new paradigm in healthcare, the procedure monitor.
The solution helps medical teams maximize treatment efficiency during and after medical procedures (e.g., resuscitation, labor, general anesthesia). It provides the team members with valuable real-time information that is adaptive to their actions and to the procedure’s stage, even if they are under pressure or can’t recall procedure steps by heart. AlephBot also automatically documents the medical procedure, which serves for both medical education and medico-legal purposes.

** AlephBot uniqueness **
We capture the human perspective of a procedure by analyzing the relevant info from the on-going structural medical conversation. We add this layer to the data collected from other sources.
Therefore, we gain higher accuracy of the analyzed medical situation, which enables us to identify the procedure stage and provide meaningful info, in real-time.

** Status **
AlephBot is developing its core technology. The company, pre-seed funded, was selected to the DRIVE accelerator at the Technion (Israel institute of Technology), and received grants from the Israel Innovation Authority.
AlephBot cooperates with big and small hospitals from day one. This serves our intention to increase treatment efficiency both in mega-hospitals in big cities and in smaller ones in the periphery and rural areas.

AlephBot is active in its target markets (Germany, France, Italy and the US) and won several national and international (France, Germany, Denmark) events and competitions. The company is still not active in China - an opportunity!

** Next steps **
We are currently looking for seed investment to finalize our core technology development and bring the product to clinical trial stage in two years. Sales are planned in three years, post regulation clearance.

Allakos is a public-traded clinical-stage biopharmaceutical company developing first-in-class antibody-based therapeutics to treat allergic and inflammatory diseases.

Allegro 3D is an emerging 3D printing and bioprinting company located in San Diego, a world hub for biotechnology. At the convergence of advanced additive manufacturing, stem cell biology and biomaterials, Allegro 3D’s expertise in bioprinting and biomaterials enables high-throughput manufacturing of advanced biomedical devices, cell matrices and precision human tissues for cell culture, drug screening, therapeutics and regenerative medicine.

Using the world’s most advanced bioprinting technologies developed at the University of California San Diego, Allegro 3D is poised to provide customers with transformational biofabrication solutions that will revolutionize healthcare innovations related to regenerative medicine, drug discovery, and biomedical research.

Clinical stage Biopharma