Exhibit
99.1
Galmed
Announces Successful First-in-Human Proof-of-Concept Clinical Study Results for Colospan’s Novel Intraoperative Tissue Assessment
Technology
| ● | The
prospective, single-arm study enrolled 32 colorectal cancer patients at three leading clinical
centers in Israel. The primary objective was to demonstrate feasibility of intraoperative
quantitative measurement of colon tissue quality. |
| ● | The
study establishes the clinical foundation for novel intraoperative tissue assessment technology,
with an aim to expand Colospan’s product pipeline with a second technology platform
for Colorectal Surgery. |
| ● | The
new technology platform, which complements Colospan’s CG-100 intraluminal bypass device,
is designed to advance Galmed’s strategy to build a leading innovative medtech and
biotech company addressing unmet needs in GI oncology and colorectal surgery. |
Ramat-Gan,
Israel, AUG. 19, 2026 – Colospan Ltd., a wholly owned subsidiary of Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD),
today announced the successful completion of a feasibility study supporting the development of a novel intraoperative colon tissue quality
assessment platform. The technology represents Colospan’s second platform, expanding the its innovation pipeline beyond
its lead product, CG-100, and reinforcing Galmed’s strategy of building a diversified portfolio of technologies addressing significant
unmet needs in colorectal surgery.
The
feasibility study enrolled 32 colorectal cancer patients undergoing elective colorectal surgery at three leading Israeli medical centers.
The study successfully demonstrated that quantitative measurement of colon tissue compliance is technically feasible using a novel ex-vivo
methodology. Successful measurements obtained in all 32 patients with no measurement failures or procedure-related technical issues.
These results establish the clinical foundation for continued development of an intraoperative device intended to objectively evaluate
colon tissue quality during surgery.
The
new platform is being developed to provide surgeons with objective, quantitative measurements of colon tissue quality during colorectal
surgery. By providing real-time information regarding tissue mechanical properties, the technology is intended to provide objective information
that may ultimately support intraoperative surgical decision-making. This may contribute over time to a better understanding of tissue
properties relevant to surgical planning prior to creation of a colorectal anastomosis, and may potentially help surgeons identify patients
at increased risk of developing Low Anterior Resection Syndrome (LARS).
Allen
Baharaff, President and CEO of Galmed Pharmaceuticals, commented:
“The
acquisition of Colospan was driven by our conviction that the company represents far more than a single-product opportunity. We recognized
an innovation platform with deep scientific expertise, a differentiated technology portfolio and the ability to develop multiple solutions
addressing significant unmet needs in colorectal surgery. The data we are publishing today support our belief that Colospan’s engineering
concepts have the potential to transition effectively into real-world clinical use. We believe that the data give Colospan a strong foundation
for the continued development of the platform and support our plans to advance toward future clinical trials and regulatory submissions.”
Boaz
Assaf, Founder and Chief Executive Officer of Colospan, commented:
“The
tissue assessment platform complements CG-100 Intraluminal Bypass Device, Colospan’s investigational device designed to provide
an alternative to diverting stomas following low anterior resection. Together, these technologies reflect Colospan’s long-term
strategy of developing innovative solutions that address critical challenges across the continuum of colorectal cancer surgery from intraoperative
tissue quality assessment to postoperative healing and recovery.”
About
Colospan
Colospan
Ltd., a wholly owned subsidiary of Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), is a commercial-stage medical device company headquartered
in Kfar Saba, Israel. Its flagship product, CG-100, is an intraluminal bypass device designed to protect colorectal anastomoses and reduce
the need for diverting stomas, offering a less invasive alternative to standard surgical practice. CG-100 was granted FDA Breakthrough
Device Designation, is CE marked under the EU Medical Device Regulation, and is approved for investigational use in the United States
under an FDA approved IDE. The device is not approved for commercial use in the US. For more information, visit www.colospan.com.
About
Galmed Pharmaceuticals
Galmed
Pharmaceuticals Ltd. (NASDAQ: GLMD) is an Israel-based biopharmaceutical company headquartered in Ramat Gan, with a growing focus on
gastrointestinal and oncological innovation. Galmed’s flagship asset, Aramchol, is a first-in-class synthetic fatty acid-bile acid
conjugate molecule under evaluation across liver disease and oncological indications, including GI cancers. For more information, visit
www.galmedpharma.com
Forward-Looking
Statements
Forward-looking
statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking
statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could
cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking
statements may include, but are not limited to, statements relating to the continued development, clinical evaluation and regulatory
advancement of Colospan’s tissue assessment platform; the potential benefits, capabilities and clinical applications of the technology;
the expansion of Colospan’s product pipeline; the expected benefits of Galmed’s acquisition of Colospan; and Galmed’s
business strategy and growth plans. Many factors could cause our actual activities or results to differ materially from the activities
and results anticipated in forward-looking statements, including, but not limited to, our inability to recognize the anticipated benefits
of the acquisition of Colospan; expectations with respect to future performance and growth of Colospan; the development and approval
of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as
metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical
or clinical trials of CG-100, Aramchol or any other medical device or product candidate we develop; completion and receiving favorable
results of any pre-clinical or clinical trial; regulatory action with respect to CG-100, Aramchol or any other medical device or product
candidate by the U.S. Food and Drug Administration, or the FDA, or the European Medicines Authority, or EMA, including but not limited
to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of
the approved indication and labeling; the commercial launch and future sales of CG-100, Aramchol and any future medical devices or product
candidates; our ability to comply with all applicable post-market regulatory requirements for CG-100, Aramchol, or any other medical
device or product candidate in the countries in which we seek to market the product; our ability to achieve favorable pricing for CG-100,
Aramchol, or any medical device or other product candidate; third-party payor reimbursement for CG-100, Aramchol, or any other medical
device or product candidate; our estimates regarding anticipated capital requirements and our needs for additional financing; market
adoption of CG-100 Aramchol or any other medical device or product candidate by physicians and patients; the timing, cost or other aspects
of the commercial launch of CG-100, Aramchol or any other medical device or product candidate; our ability to obtain and maintain adequate
protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our
ability to manufacture our CG-100 or product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our
ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having
substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales,
distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current
or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity
risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and the security, political and economic
instability in the Middle East that could harm our business, including due to the current security situation in Israel. We believe these
forward-looking statements are reasonable; however, these statements are only current predictions and are subject to known and unknown
risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or
achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in our
Annual Report on Form 20-F for the year ended December 31, 2025, filed with the SEC on March 31, 2026 in greater detail under the heading
“Risk Factors.” Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events.
All forward-looking statements attributable to us or persons acting on our behalf speak only as of the date hereof and are expressly
qualified in their entirety by the cautionary statements included in this report. We undertake no obligations to update or revise forward-looking
statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In
evaluating forward-looking statements, you should consider these risks and uncertainties.
Investor
and Media contact:
Guy
Nehemya, +972-3-693-8448, investor.relations@galmedpharma.com
