Future | Market Reshaped





1. STRATIFICATION OF SURGICAL STAPLING PRODUCT MARKET



Generation 1: the currently marketed, legacy surgical stapling products


Generation 2: the reinvented surgical stapling products including adjunct specialty products supporting the expanded

parameterization and novel surgical staplers based on the new stapling methods/technologies






2. BASIS OF GENERATIONAL EVOLUTION OF SURGICAL STAPLING PRODUCT



2.1. Scientific Foundation Broadened


- The Gen. 1 surgical stapling product, not including those with steps or bumps

on the staple cartridge deck and offset leg staples, were based on a scientific foundation, albeit rudimentary.


- The scientific foundation and associated parameterization of the Gen. 2 surgical stapling product are broadened in

multiple steps with progressively increasing complexities to enable analysis of appropriate scientific rigor required to

properly understand the surgeon user experiences with the products in clinical setting and to analyze and identify the

root causes of adverse events reported to the FDA.



2.2. Informed Clinical Decision Making Enabled



Newly available to the surgeon users are:


- A new set of adjunct analytical instruments designed to enable quantification of selected new parameters associated

with the broadened scientific foundation of the Gen. 2 surgical stapling product.


- A new set of adjunct analytical instruments designed to enable in-situ inspection and evaluation of performance of

surgical stapling products



2.3. Regulatory Clearance Framework Redefined



The key elements for the 510(k) framework would be in tune with the well established scientific research methodology

and updated to accommodate the broadened scientific foundation of the Gen. 2 surgical stapling products.






3. COMPETITIVE BARRIERS FOR THE GEN. 2 SURGICAL STAPLING PRODUCT



3.1. The trade secret - The broadened scientific foundation of the Gen. 2 with distance to the nearest competitor of

5~10 calendar years PROVIDED that the academic, scientific research on the art of surgical stapling as well as critical

analysis of the real world, surgeon user experiences and reported adverse events are diligently and continually

performed by scientist(s) highly trained (15~20 years) in the basic science research closely alongside the technological

development projects for surgical stapling products which, in turn, must be carried out solidly guided by the

knowledges and findings resulting from the academic and real world scientific research.



3.2. The intellectual property - 40~50 patented and patentable intellectual properties (not counting off-springs) with

distance to the nearest competitor of the duration of patent rights in addition to the time required for the academic

and real world scientific research to reach a certain degree of maturity



3.3. The redefined regulatory framework



Future | Endoscape Surgical, A Startup





A PIONEER OF THE NEW GENERATION IN HAND-HELD AND (IN PARTNERSHIP) ROBOTIC ASSISTED SURGICAL

STAPLING*



1. The currently marketed hand-held surgical stapling products, built on a heuristic ground without a scientific

basis, are inevitably destined to become obsolete first and foremost due to a regulatory non-compliance failing to

satisfy a fundamental aspect of the science-driven FDA 510(k) regulation*,**.


2. Solidly supported by the Safer and Breakthrough Technologies recognized by the FDA (see Webpage "Home")

the products of ENDOSCAPE SURGICAL will be able to command a dominant position in the global surgical stapling

market for the foreseeable future.


3. The true value of Endoscape Surgical's technologies and products will gradually manifest itself over time through

their contribution in systematically addressing and providing solutions for the historical adverse events associated

with use of surgical stapling products reported and stored in the FDA MAUDE database over decades that have been

largely neglected by the manufacturers of currently marketed surgical stapling products.





BUSINESS MODEL



1. Rapidly build up capabilities to develop and manufacture the identical clones of the manual type surgical stapler

instruments and associated flat deck staple cartridges of one of the leading manufacturers, pair them up with a

Tissue Probe device (an Overload Indicator type) and compete head-to-head with manufacturers of the currently

marketed stapling products.


2. In seeking a regulatory marketing clearance for the clone surgical stapling products strictly adhere to the

science driven "Redefined 510(k) Framework" (see above Section "Future | Market Reshaped") to provide a constructive,

scientific and logical foundation for the FDA to strengthen the 510(k) regulatory framework for surgical stapling

products and finally abolish the hopelessly outdated and inherently unscientific grandfathering practice

in administering its regulatory authority.







HEADQUARTER: SANTA CLARA, CA, USA



* Please see a citizen petition to the FDA , Docket ID FDA-2025-P-6523 in www.regulations.gov. Link provided below.

** Please see the interim response from the FDA to Dockets ID FDA-2025-P-5371 and 5435. Link provided below.


FDA Interim Response Endoscape Surgical
 Docket 6523

* The products displayed on this website are under development and have not been cleared or approved for marketing by any regulatory agency. The contents of

this website may be updated in the future without prior notice.