Member Info for havegun

Like some on here will be worrying after that update.

No problem,must keep up to date.

Mr. Billy Williams bwilliams@innomedtec.com Mr. Stuart J. Bromley +33 (0) 788 26 80 35 Bromley@CICCapital.com www.Innomedtec.com Innomed Tech Ltd. The Company’s first medical device development subsidiary, PureFlowCath, is developing the PureFlowCath Catheter System to provide continuous irrigation (“CSCI) with the objective of reducing urinary tract infections commonly associated with the use of a urinary catheter. Catheter associated urinary tract infection (CAUTI) is the most frequent healthcare associated infection (HAI) worldwide. It accounts for up to 40% of all hospital acquired infections and results in over 13,000 deaths annually in the United States alone according to data from the Centre’s for Disease Control and Prevention (CDC). The Company is progressing a listing on a regulated, designated stock exchange through a Non-Offering Long Form Prospectus

Corporate Update – 29 January 2025 Innomed Tech Ltd. (BC Canada) (the “Company”) is pleased to provide the following corporate update. Development of PureFlowCath Catheter development to market. The Company and Cambridge Consulting have commenced the first phase to progress the full design and development of the PureFlowCath Catheter to market. The development process will follow US Federal Drug Administration (FDA) Recommended Waterfall Medical Device Design Process to Market. The Company’s development costs are largely funded by the proceeds raised by CIC Fund Securitisation S.A. (Luxembourg) finance over the last few years. Audit Update. McGovern Hurley, the Company’s new auditor, has advised that the audit of the year ended December 31, 2023 has been completed and the review of the interim financial statement to 30 September 2023 is expected to be completed mid-February 2025. McGovern Hurley had to review the prior year audits conducted by the previous auditor RSM Canada. Following the completion of financial audit, the Company will advise of the date of annual general and shareholder meeting but is expected to be held in March 2025 by proxy voting. Progress of listing on the TSX Venture Exchange (TSXV) The prospectus regulator review was largely complete save updating the prospectus with the required financial statements. The TSXV review will be undertaken once the prospectus is filed. The Company will file the updated prospectus on completion of McGovern Hurley’s sign off of the financial statements expected mid-February 2025.

That the group action is still open.first it was 17th November for it to close then end of November.Next week we will know if after the conference everything is above board so why bother throwing money at a lawyer for nothing.

Time now.

Do not read many messages on here because I have green boxed most.I get the impression though that a great deal of them do not want things to succeed and would rather see failure so they can feel righteous by taking their venom on Amit.

Phase 2 - 4: Engineering Verification First pass formal testing to ensure the designed device meets

the requirements and is safe and effective for use. Lower

sample numbers to give confidence in device performance

and make any minor updates required before formalised

statistically significant testing in Phase 5

• Testing the pre-production device to verify that it meets

the requirements and are safe for use before the design

is chilled.

• Development of detailed test protocols for

demonstrating that the product requirements have

been met, this will likely include development of

specific jigs and fixtures to test device functionality.

• Functional and non-functional testing, e.g.,

performance over operating temperature; drop,

impact, and crush tests; transportation testing;

biocompatibility (if required)

Design Review 4: Design is “chilled” * and

ready for formal verification

testing.

~ 6 months

*(no major changes

expected, minor

modifications may be

required depending on

testing outcome)

Phase 2 - 5: Design Verification Design Review 5: ~6 months

Formal testing of the device to demonstrate that it meets the

Product Requirements; This formal testing will be conducted

larger sample numbers to gather statistically significant data.

Some of this testing will be conducted by independent test

houses:

• Updated manufacturing quality plan

• Build verification units (including component logs,

master record index etc)

• Conduct formal verification activities.

• Update risk management file.

• Design verification report

Design has demonstrated

that it meets the

requirements and is safe and

effective for use. Design is

frozen and ready for

validation

• Design verification report

Phase 2 - 6: Design Validation and Regulatory Submission Design Review 6: Testing and assessment to demonstrate that the product

Device and accompanying

addresses the user needs defined in the intended use

technical file are ready for

statement:

regulatory submission and

volume manufacture • Manufacturing process optimisation support.

• Build validation and clinical units (if required).

• Summative Usability study.

• Clinical trial support (if required)

• Compile technical file or regulatory submission.

• Support for regulatory submission process.

• Support for regulatory submission process.

Each Phase may be conducted in parallel with other Phases.

Lows:

Phase 2 - 1: Design Inputs Typically Phase 1 goals focus on establishing specific

performance targets and resolving any priority risks;

effectively establishing that the fundamental science is

sound and understood, and the constraints the product

needs to meet to be considered viable.

• Activities include:

• Product brief

• Intended Use

• User / Stakeholder requirements (clinical, user,

regulatory, commercial)

• Quality Plans (design, risk, etc)

• Translate into draft requirements specification (PRS, IFU,

Packaging etc)

• Hazard Identification (risk management inc. clinical)

• Review system architecture and create draft relevant

sections of the product design description.

• Updated detailed development plan (costed)

• Identify potential catheter manufacturing partners

Phase 2 - 2: Technical De-risking This is the critical time in the programme to be sure that the

intended solution can reduce the formation of biofilm and

reduce infection risk. This assessment should be completed

prior to detailed design to manage risk vs investment. Rapid

prototype and low-volume prototypes devices will be used to

facilitate testing. Activities include:

• Development and de-risking of critical novel features (e.g.,

elution) to demonstrate proof that the design can function

as intended.

• Develop test methods.

• Identification of clinical research needs and support

selecting a partner if required.

Phase 2 - 3: Detailed Design The detailed design phase of the programme focuses on

integrating the de-risked technical components into a volume-

manufacturable device. Activities include:

• Risk Analysis (Use, Design, Manufacturing)

• Formative Usability Study

• Verification / Validation planning

• Detailed mechanical design and analysis (3D CAD,

engineering drawings, tolerance analysis, FEA, CFD etc)

• Confirmation of suppliers for prototype build (may differ

from volume manufacture)

• First-off off (prototype) Build, including test jigs and

fixtures

• Manufacturer selection support

• Liaison with chosen manufacturing partner

Design Review 1: ~3 months

Design Inputs are defined,

regulatory and clinical

pathway understoThe

PHASE 2 FDA Recommended Waterfall Medical Device Design Process to Market

The following projection of workflow is forward looking and may be subject to changes and only

focuses on PureFlowCath Catheter development.

Following the award of the EU patent the subsequent IP protection enables the final Phase 2

development programme for PureFlowCath Catheter to market following the completion of Phase

1, building on the passed initial work ensuring mandatory FDA & EU regulatory compliant design

control processes are followed. The phases of work and milestones provides the highest

standards for regulatory submissions.

Cambridge Consultants will take responsibility for guiding the overall development process with board

oversight. As a medical device with specialist manufacturing requirements, the Company will involve

a catheter manufacturing and or a global catheter distributor early in the development. This enables

Cambridge Consultants to focus on enabling the novel, high value aspects of the PureFlowCath Catheter

whilst avoiding spending time & effort ‘re-inventing the wheel’ for more conventional elements of the

This in my spam box today. CORPORATE UPDATE

Released 09:39:14 10 December 2024

RNS Number : 5130P

InnoMed Tech Ltd.

10 December 2024

Innomed Tech Ltd.

Corporate Update

Innomed Tech Ltd. (BC Canada) (the "Company") is pleased to announce the following corporate update on the

development of PureFlowCath Catheter development to market.

The Company is developing the PureFlowCath Catheter System to provide continuous irrigation (CSCI) with the

objective of reducing urinary tract infections commonly associated with the use of a urinary catheter.

Following the successful European Patent award recently and the completion of initial phase of development, the

Company has appointed Cambridge Consulting to progress the full design and development of the PureFlowCath

Catheter.

The development process will follow US Federal Drug Administration (FDA) Recommended Waterfall Medical Device

Design Process to Market.

The Company development costs are largely funded by proceeds raised by CIC Fund Securitisation S.A.

(Luxembourg) finance.

Mr. Billy Williams bwilliams@innomedtec.com

Mr. Stuart J. Bromley +33 (0) 788 26 80 35 Bromley@CICCapital.com

www.Innomedtec.com

Innomed Tech Ltd.

The Company's first medical device development subsidiary, PureFlowCath, is developing the PureFlowCath Catheter

System to provide continuous irrigation (CSCI) with the objective of reducing urinary tract infections commonly

associated with the use of a urinary catheter.

Catheter associated urinary tract infection (CAUTI) is the most frequent healthcare associated infection (HAI)

worldwide. It accounts for up to 40% of all hospital acquired infections and results in over 13,000 deaths annually in

the United States alone according to data from the Centre's for Disease Control and Prevention (CDC).

The Company is progressing a listing on a regulated, designated stock exchange through a Non-Offering Long Form

Prospectus.

About Cambridge Consulting

Cambridge Consulting founded in 1960 are innovating in some of the most prominent deep tech fields, including

artificial intelligence, biotechnology, smart connectivity, green-tech and sustainability, advanced sensing, photonics and

quantum computing. Cambridge Consulting tackle the world's toughest healthcare challenges, developing novel

products, platforms and ecosystems to improve outcomes, care delivery, patient experience, and healthcare value.

Cambridge Consulting have deep experience developing medical devices across a range of clinical applications.

Cambridge Consulting parent is Capgemini SE a French publicly listed multinational information technology services

Funding may be forthcoming coming before 14th February which would change things dramatically.

Case to answer it looks like.

Course it may have been dismissed beforehand which we should have been informed.

Was supposed to be held today.I wonder if will find out the result tomorrow.If not we need to know what is going on.

So you said this company would be bust by April 2025.You are going look the biggest idiot on here by far if it does not.I shall wait for your whining apology (you will not of course)

Approaching one way or the other.

What a waste of space . Filtered

Thought I smelled something foul.I shall get rid by deleting it

In excess of 125