News

DystropHix a subsidiary of Bioramics (“Bioramics” or the “Company”), a privately held
biotechnology company developing micronized biomaterial-based drugs to improve the
treatment of muscle diseases, announced today that the U.S. Food and Drug
Administration (FDA) has granted Orphan Disease Designation to CoO- Time Release
Ion Matrix (TRIM) for the potential treatment of Duchenne Muscular Dystrophy (DMD).
CoO-TRIM is a first-in-class injectable therapeutic designed to stimulate sustained
vascular endothelial growth factor (VEGF) elevation over 70 days post injection into
myofascial compartments, improving dystrophic muscle function and regenerative
capacity.

“Receiving the Orphan Disease Designation for CoO-TRIM from the FDA for DystropHix
is another important milestone for Bioramics as we continue to de-risk our technology
for the DMD population,” said Aaron Morton, CSO and Co-founder of Bioramics. “One
key advantage of our technology is its biomaterial-based structure, permitting delivery to
DMD patients regardless of what former genetic therapeutics they have had.”

About Orphan Disease Designation
The Orphan Drug Act provides incentives for drugs focused on improving orphan
diseases. A summary of benefits follows:
1) 7 yrs of marketing exclusivity for ODD drug sponsors
2) 25% tax credits during clinical trials applied over 20 yrs of taxes
3) Waiver of the Prescription Drug User Fee (valued at $3.2M in 2023)
4) Ability to compete for OOPD grants
5) Eligibility to receive regulatory guidance from the FDA to design the overall drug
development plan

About CoO-TRIM
CoO-TRIM is Bioramics’ lead compound, and a micronized biomaterial drug designed to
promote sustained, endogenous growth factor release over months without
demonstrating any toxicity or negative side effects. Thus, presenting a new mechanism
of action with high clinical relevance for treating symptoms of DMD.

About Duchenne Muscular Dystrophy
DMD is one of the most common genetic diseases in males, promoting repeated muscle
damage, resulting in adolescent immobility and eventual paralysis. Poor muscle stem
cell function and regeneration is common. Bioramics designed CoO-TRIM to function as
a stand alone therapeutic, restoring local muscle function. Regardless of disease
severity or prior treatments, CoO-TRIM can be used. Also, CoO-TRIM may enhance the
efficiency of systemic therapeutics, making it a desirable candidate for combination
therapy.

About Bioramics
Bioramics is a privately held platform company offering private equity in subsidiary
companies holding rights to developing therapeutics. Bioramics seeks qualified
partnerships to accelerate the development of its therapeutics.

Notice on Forward-Looking Statements
This press release includes forward-looking information or forward-looking statements
within the meaning of applicable securities laws regarding Bioramics and its business,
which may include, but are not limited to, statements regarding the value of our DMD
program; the advancement of our lead drug candidate into clinical trials; the general
benefits of biomaterial based drugs; its/their prospective impact on DMD patients and
on muscle regeneration generally; the utility of regenerating muscle by promoting
endogenous growth factor release; adoption of Bioramics’ approach by the medical
community; and Bioramics’ technologies and drug development plans. All statements
that are, or information which is, not historical facts, including without limitation,
statements regarding future estimates, plans, programs, forecasts, projections,
objectives, assumptions, expectations or beliefs of future performance, occurrences or
developments, are “forward-looking information or statements.” Often but not always,
forward-looking information or statements can be identified by the use of words such as
“shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”,
“anticipate”, “potential”, “prospective” , “assert” or any variations (including negative or
plural variations) of such words and phrases, or state that certain actions, events or
results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in,
or, be achieved. Such statements are based on the current expectations and views of
future events of the management of the Company. They are based on assumptions and
subject to risks and uncertainties. Although management believes that the assumptions
underlying these statements are reasonable, they may prove to be incorrect. The
forward-looking events and circumstances discussed in this release, may not occur and
could differ materially as a result of known and unknown risk factors and uncertainties
affecting the Company, including, without limitation, risks relating to the pharmaceutical
and bioscience industry (including the risks associated with preclinical and clinical trials
and regulatory approvals), and the research and development of therapeutics, the
results of preclinical and clinical trials, general market conditions and equity markets,
economic factors and management’s ability to manage and to operate the business of
the Company generally, including inflation and the costs of operating a biopharma
business. Although Bioramics has attempted to identify important factors that could
cause actual actions, events or results to differ materially from those described in
forward-looking statements, there may be other factors that cause actions, events or
results to differ from those anticipated, estimated or intended. Accordingly, readers
should not place undue reliance on any forward-looking statements or information. No
forward- looking statement can be guaranteed. Except as required by applicable
securities laws, forward-looking statements speak only as of the date on which they are
made and Bioramics does not undertake any obligation to publicly update or revise any
forward-looking statement, whether resulting from new information, future events, or
otherwise

Contacts:
Investors: Joseph Foster, joe.foster@bioramics.com
Business Development: Rob Rosenberger, rob.rosenberger@bioramics.com