AiViva is a clinical stage biotech company which has created proprietary technology and new treatments to address significant, unmet medical needs in ophthalmology, dermatology, urology, and oncology. The company is led by a team of seasoned industry experts who have an outstanding track record in successful drug development, commercialization, and multiple IPOs on the NYSE and NASDAQ.

  • AiViva already has successfully raised over $25 million USD, with $4.2 million raised in 2022 alone.
  • Our diverse product pipeline presents a combined revenue potential of $5.3B. We have four clinical trials (two ongoing, two planned) focused on wet AMD, prostate disorders, and non-melanoma skin cancer.
  • We have a veteran team with over 300 years of combined experience. AiViva is rated as a top 20 BioPharma company in 2022 by Life Sciences Review.

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AiViva's mission is to develop novel, innovative pharmaceutical products through an efficient development strategy to
address major unmet medical needs. We have four clinical trials (two ongoing, two planned) focused on wet AMD,
prostate disorders, and non-melanoma skin cancer.

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Our proprietary JEL™ Technology prolongs the therapeutic effects of drugs and enhances their benefit, thereby reducing treatment frequency, relieving the burden for patients and physicians, and improving outcomes.

AiViva's proprietary JEL™ technology will allow placement of the drug directly at the site of disease and will form a drug depot for prolonged drug release, thereby delivering an effective therapy. This JEL™ Technology is unique because the delivery medium is a liquid at room temperature, and upon injection into the diseased tissue at body temperature, it transforms into a jello-like mass. This drug containing "jello" serves as a drug depot that releases the drug over time.

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AiViva has successfully raised capital & demonstrated positive human results in three areas

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AiViva's funds are allocated extremely efficiently. We put roughly 80% of our raised capital to research and development. AiViva has brought several projects through FDA's IND (Investigational New Drug Application) and demonstrated positive proof-of-concept in clinical trials in three areas:

1. Vision improvement by reducing retina swelling and scarring
2. Fibrosis reduction (thus reducing scarring potential) for surgical incisional wounds
3. Histological clearance of basal cell carcinoma and nodular carcinoma

These large market potentials are protected by AiViva's patent applications in major markets including Europe, Japan, China, and the US beyond the year 2040.

CF-5_62 Worldwide patent

Imagine losing your sight, day by day

Wet age-related macular degeneration (also known as wet AMD) is a chronic eye disorder that causes blurred vision or a blind spot in your visual field. It's generally caused by abnormal blood vessels that leak fluid or blood and scars the macula, the area of the eye that provides the sharp, central vision needed for reading, driving and seeing fine detail. (Source)

Current and emerging therapies treating this disorder tend to only address neovascularization (abnormal blood vessel growth) - resulting in unsatisfactory treatment outcomes of long-term visual loss. The goal of an ideal treatment is to address all underlying causes of the disease - e.g., abnormal blood vessel growth and scar formation - to help patients to keep more of their vision and prevent further vision loss over time.

AiViva has a special focus on wet AMD. The drug of interest is AIVOO7, which addresses neovascularization, inflammation, and fibrosis (scarring), causes of wet AMD and thus impaired vision. AIVOO7 is delivered in JEL™ to prolong the treatment duration.

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Dermatology
Dermatology
Ophthalmology
Ophthalmology
Urology
Urology
Oncology
Oncology

Other major diseases which involve neovascularization, abnormal tissue growth, and fibrosis include cancers, benign hyperplasia, and skin disorders. Our next clinical trial will focus on prostate disorders. Starting around age 25, hyperplasia, or enlargement, of men's prostates occurs and continues over time. Symptoms of benign prostate hyperplasia may start to present as early as age 40. These symptoms may include frequent urination throughout the day and night, dribbling at the end of urination, and inability to fully empty the bladder. Benign prostate hyperplasia and prostate cancer may happen at the same time.

AiViva has ongoing clinical trials in skin cancer and keloid scarring using compound AIV001.

Discovering therapeutics to address major unmet medical needs

Our innovative discoveries provide novel pharmacotherapy and reduce the treatment burden for both patients and physicians.

Our proprietary JEL delivery platform offers customizable drug release and treatment duration. It will potentially lead to many novel treatments for major diseases.

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AiViva is positioned to bring new treatment options to benefit patients, and here's how:

1.AIV007

AIV007 is a novel compound which targets all of the key pathways leading to neovascularization, cell proliferation, and fibrosis. Its receptor targets are VEGFR, PDGFR, and FGFR, and it also modulates TGFβ1 mRNA expression and TGFβ1 levels to reduce collagen production and scarring.

AIV007, when embedded in JEL™, has the potential to be effective in treating wet AMD, benign prostatic hyperplasia (BPH), low grade prostate cancer, and certain solid tumors.

2.AIV001

AIV00l is an extremely potent kinase receptor inhibitor and has been demonstrated to reduce neovascularization and cell proliferation associated with certain cancers in patients. AIV00l may also modulate inflammation and fibroplasia, causes of scarring.

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Our diverse pipeline presents a large, combined market potential

The indications AiViva are targeting represent a combined revenue potential of $5.3B.

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a. See CDC for AMD prevalence number estimates (https://www.cdc.gov/visionhealth/basics/ced/) - the US prevalence for all retinal diseases is estimated to be 11M; US Retina Market was >$7B annually in years of 2018-2020. Eylea sales in 2020 were $8.36 billion globally and $4.95 billion in the U.S. Source: Company annual financial reports for Regeneron, Genentech, Roche and Novartis.

b. Internal forecast based on achieving a target product profile that would offer clear differentiation from competitors in several key aspects such as prolonged dosing interval 3-6 months, early onset of vision improvement, reversal of retinal scarring, and long-term positive visual outcome and favorable reimbursement.

c. See CDC for non-melanoma skin cancer (NMSC) prevalence number estimates (https://www.cdc.gov/cancer/skin/statistics/) and the CDC estimate that NMSC has a treatment cost of about $4.8 billion. AIV001 could also be developed for Actinic Keratosis besides squamous cell carcinoma (SCC) and basal cell carcinoma (BCC).

d. Internal forecast based on achieving an indication in both SCC and BCC with a target product profile that would offer a novel drug delivery modality with enhanced benefit-risk outcome, competitive as compared to Standard-of-Care surgical option and providing maximal cosmetic effect while being patient friendly and favorable reimbursement.

e. Internal estimation of the addressable keloid market available for AIV001. There is no FDA approved therapies for hypertrophic or keloid scarring; current treatments are topical ointments, gels, and creams, pressure dressing, and steroid Injections. See American Academy of Dermatology (https://www.aad.org/public/diseases/a-z/scars-treatment). Besides preventative measures Keloid scars can also be treated with surgery (https://www.aad.org/public/diseases/a-z/keloids-overview).

f. Internal forecast based on a target product profile of an injectable agent that would offer superior local efficacy for the treatment of keloid scarring post-surgery from one to three treatments every 2-4 weeks, and no local skin reactions. The treatment would be an in-office treatment and would be assumed to offer favorable reimbursement to HCPs. AIV001 could also be developed for hypertrophic scarring and for scarring related to post-carpal tunnel surgery.

g. See National Cancer Institute (https://seer.cancer.gov/statfacts/) for Prostate cancer and for other solid tumor cancers of breast, kidney, and thyroid that could be applicable for AIV007.

h. Internal forecast based on a target product profile as a localized intra-prostatic injection to provide cancer clearance without the sexual effects such as erectile dysfunction and urinary incontinence common with surgical and radiation treatments for prostate cancer (https://www.pcf.org/about- prostate-cancer/prostate-cancer-side-effects/surgery-side-effects/). AIV00l would target Prostate cancer patients who are on early stage, active surveillance and would be offered as a non-surgical option. AIV007 could also be developed for breast (DCIS and non-DCIS), kidney, and thyroid cancers, respectively.

Illustration_Treatment_V04

Bringing transformative therapies to millions of patients

AiViva believes in continuing the advancement and development of innovative and novel treatment paradigms.

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We are dedicated to our vision and committed to bringing transformative therapies to the millions of patients living with diseases that negatively impact their lives.

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