| 2025/05/23 | 15:48:45 | BOD of Medeon’s major subsidiary PMC re-elected Mr. Yue Teh Jang as the Chairman. | |
| SEQ_NO |
6 |
Date of announcement |
2025/05/23 |
Time of announcement |
15:48:45 |
| Subject |
BOD of Medeon’s major subsidiary PMC re-elected Mr. Yue Teh Jang as the Chairman. |
| Date of events |
2025/05/23
|
To which item it meets |
paragraph 6 |
| Statement |
1.Date of the board of directors resolution or date of occurrence of the
change:2025/05/23
2.Position (Please enter chairperson or president/general manager):
Chairperson
3.Name of the previous position holder:Yue Teh Jang
4.Resume of the previous position holder:Chairman, PMC
5.Name of the new position holder:Yue Teh Jang
6.Resume of the new position holder:Chairman, PMC
7.Circumstances of change (Please enter ‘resignation’, ‘dismissal’,
‘term expired’ , ‘job relocation’, ‘severance’, ‘retirement’,
‘death’ or ‘new appointment’):Term expired
8.Reason for the change:Term expired and re-elected
9.Effective date of the new appointment:2025/05/23
10.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 6
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):None |
|
| 2025/05/23 | 15:43:39 | Major Subsidiary PMC Announces Lifting of Non-Compete Restrictions on Directors at 2025 Annual Shareholders’ Meeting. | |
| SEQ_NO |
5 |
Date of announcement |
2025/05/23 |
Time of announcement |
15:43:39 |
| Subject |
Major Subsidiary PMC Announces Lifting of Non-Compete Restrictions on Directors at 2025 Annual Shareholders' Meeting. |
| Date of events |
2025/05/23
|
To which item it meets |
paragraph 21 |
| Statement |
1.Date of the shareholders’ meeting resolution:2025/05/23
2.Name and title of the managerial officer with permission
to engage in competitive conduct:
Medeon Biodesign, Inc.
Legal Representative of Medeon Biodesign, Inc. Yue Teh Jang; Chairman
Legal Representative of Medeon Biodesign, Inc. Albert Weng; Director
Legal Representative of Medeon Biodesign, Inc. Jenny Chen; Director
3.Items of competitive conduct in which the officer is
permitted to engage:
Invest in or manage other companies with the same or similar scope of
business as PMC
4.Period of permission to engage in the competitive conduct:
During the period of serving as director of PMC
5.Circumstances of the resolution (please describe the
results of voting in accordance with Article 209 of the
Company Act):
The proposal was resolved as proposed after the chairman inquired of all
attending shareholders.
6.If the permitted competitive conduct belongs to the
operator of a mainland China enterprise, the name and
title of the directors (if it is not the operator of
a mainland China enterprise, please enter ‘N/A’ below):N/A
7.Company name of the mainland China enterprise and the
officer’s position in the enterprise:N/A
8.Address of the mainland China enterprise:N/A
9.Operations of the mainland China enterprise:N/A
10.Impact on the company’s finance and business:N/A
11.If the directors have invested in the mainland China
enterprise, the monetary amount of the investment and
their shareholding ratio:N/A
12.Any other matters that need to be specified:None |
|
| 2025/05/23 | 15:36:53 | Announcement of the Election Results for Directors and Supervisor of Major Subsidiary PMC at the 2025 Annual Shareholders’ Meeting. | |
| SEQ_NO |
4 |
Date of announcement |
2025/05/23 |
Time of announcement |
15:36:53 |
| Subject |
Announcement of the Election Results for Directors and Supervisor of Major Subsidiary PMC at the 2025 Annual Shareholders' Meeting. |
| Date of events |
2025/05/23
|
To which item it meets |
paragraph 6 |
| Statement |
1.Date of occurrence of the change:2025/05/23
2.Elected or changed position (Please enter institutional
director, institutional supervisor, independent director,
natural-person director or natural-person supervisor):
institutional director, natural-person supervisor
3.Title and name of the previous position holder:
(1) Legal Representative of Medeon Biodesign, Inc. Yue Teh Jang; Chairman
(2) Legal Representative of Medeon Biodesign, Inc. Albert Weng; Director
(3) Legal Representative of Medeon Biodesign, Inc. Jenny Chen; Director
(4) Supervisor: Elisa Huang
4.Resume of the previous position holder:
(1) Yue Teh Jang; Chairman of PMC
(2) Albert Weng; Director of PMC
(3) Jenny Chen; Director of PMC
(4) Supervisor: Elisa Huang; Supervisor of PMC
5.Title and name of the new position holder:
(1) Legal Representative of Medeon Biodesign, Inc. Yue Teh Jang; Chairman
(2) Legal Representative of Medeon Biodesign, Inc. Albert Weng; Director
(3) Legal Representative of Medeon Biodesign, Inc. Jenny Chen; Director
(4) Supervisor: Elisa Huang
6.Resume of the new position holder:
(1) Yue Teh Jang; Chairman of PMC
(2) Albert Weng; Director of PMC
(3) Jenny Chen; Director of PMC
(4) Supervisor: Elisa Huang; Supervisor of PMC
7.Circumstances of change (Please enter ‘resignation’, ‘dismissal’,
‘term expired’, ‘death’ or ‘new appointment’):term expired
8.Reason for the change:Term expired re-elected
9.Number of shares held by the new position holder when elected:
(1) Legal Representative of Medeon Biodesign, Inc.
Yue Teh Jang; 28,761,000 shares
(2) Legal Representative of Medeon Biodesign, Inc.
Albert Weng; 28,761,000 shares
(3) Legal Representative of Medeon Biodesign, Inc.
Jenny Chen; 28,761,000 shares
(4) Supervisor: Elisa Huang; 0 shares
10.Original term (from __________ to __________):2022/05/27~2025/05/26
11.Effective date of the new appointment:2025/05/23
12.Turnover rate of directors of the same term:NA
13.Turnover rate of independent directors of the same term:NA
14.Turnover rate of supervisors of the same term:NA
15.Change in one-third or more of directors (Please enter ‘Yes’ or
‘No’):No
16.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 6
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):None |
|
| 2025/05/23 | 15:15:31 | Announcement for the important resolutions at the 2025 Annual Shareholders’ Meeting on behalf of Medeon’s major subsidiary, PMC | |
| SEQ_NO |
2 |
Date of announcement |
2025/05/23 |
Time of announcement |
15:15:31 |
| Subject |
Announcement for the important resolutions at the 2025 Annual Shareholders’ Meeting on behalf of Medeon’s major subsidiary, PMC |
| Date of events |
2025/05/23
|
To which item it meets |
paragraph 18 |
| Statement |
1.Date of the shareholders’ meeting:2025/05/23
2.Important resolutions I.Profit distribution/deficit compensation:
Ratification of 2024 deficit offset proposal
3.Important resolutions II.Amendments of the company charter:None
4.Important resolutions III.Business report and financial statements:
Ratification of 2024 Business Report and Financial Statements
5.Important resolutions IV.Election for directors and supervisors:
Election the 4th session of Directors and Supervisor
6.Important resolutions V.Other matters:
Approval for the release of newly elected directors or its representatives
from Non-Competition Restrictions.
7.Any other matters that need to be specified:None |
|
| 2025/05/23 | 15:09:04 | Announcement for the important resolutions at the 2025 Medeologix Annual Shareholders’ Meeting, on behalf of the major subsidiary, Medeologix | |
| SEQ_NO |
1 |
Date of announcement |
2025/05/23 |
Time of announcement |
15:09:04 |
| Subject |
Announcement for the important resolutions at the 2025 Medeologix Annual Shareholders’ Meeting, on behalf of the major subsidiary, Medeologix |
| Date of events |
2025/05/23
|
To which item it meets |
paragraph 18 |
| Statement |
1.Date of the shareholders’ meeting:2025/05/23
2.Important resolutions I.Profit distribution/deficit compensation:
Ratification of 2024 deficit offset proposal
3.Important resolutions II.Amendments of the company charter:None
4.Important resolutions III.Business report and financial statements:
Ratification of 2024 Business Report and Financial Statements
5.Important resolutions IV.Election for directors and supervisors:None
6.Important resolutions V.Other matters:None
7.Any other matters that need to be specified:None |
|
| 2025/05/15 | 15:14:37 | The Company has been required by TPEx to announce the financial data according to the regulations. | |
| SEQ_NO |
1 |
Date of announcement |
2025/05/15 |
Time of announcement |
15:14:37 |
| Subject |
The Company has been required by TPEx to announce the financial data according to the regulations. |
| Date of events |
2025/05/15
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event: 2025/05/15
2.Cause of occurrence:Announced as required by the TPEx
3.Financial and business information:
Unit: (NT$million)
(1) Monthly
April 2025 April 2024 YoY Change %
—————————————————————————
Sales revenue 35.914 20.738 73.18%
Loss before income tax (64.912) (73.120) 11.23%
Net Loss attributable to
Owners of the parent (61.889) (62.427) 0.86
EPS (NT$) (0.67) (0.68) 1.47%(‘?l’?)
===========================================================================
(2)Quarterly
Q1 2025 Q1 2024 YoY Change %
—————————————————————————
Sales revenue 101.878 47.141 116.11%
Loss before income tax (190.856) (214.799) 11.15%
Net Loss attributable to
Owners of the parent (177.993) (199.827) 10.93%
EPS (NT$) (1.93) (2.17) 11.06%(‘?l’?)
===========================================================================
(3)Cumulative for the last four seasons
Latest 4 quarters accumulation
(Q2 2024 to Q2 2025)
—————————————————————————
Revenue 347.545
Loss before income tax (834.700)
Net Loss attributable to
Owners of the parent (783.678)
EPS (NT$) (8.50)
===========================================================================
4.Any material information that needs to be specified
according to Article 4 of Taipei Exchange Procedures
for Verification and Disclosure of Material Information
of Companies with TPEx Listed Securities:
On May 7, 2025, Medeon announced the content of material information press
conference, disclosing the preliminary clinical results for the IDE Study
in evaluating its BPH minimally invasive treatment device Urocross.
5.Any material information in a press conference listed
under Article 11 of Taipei Exchange Procedures for
Verification and Disclosure of Material Information of
Companies with TPEx Listed Securities:
On May 7, 2025, Medeon announced to host the material information press
conference, disclosing the preliminary clinical results for the IDE Study
in evaluating its BPH minimally invasive treatment device Urocross.
6.Any other matters that need to be specified:
(1)The aforementioned financial information for April 2025 and its YOY
comparison consists in the consolidated reviewed amounts prepared by
the Company adopting the IFRS, and has not been audited (reviewed)
by CPA; it is only for reference by investors.
(2)The information for the latest quarter (Q1 2025) refers to single
quarter amounts, not cumulative amounts from the latest financial
reports, and are consolidated amounts prepared under the IFRS,
which have been audited (reviewed) by CPA; it is only for reference
by investors.
(3)The information accumulated over the last 4 quarters consists in the
consolidated amounts from Q2 2024 to Q1 2025 prepared by the Company
adopting the IFRS, and has been audited (reviewed) by CPA; it is only
for reference by investors. |
|
| 2025/05/14 | 23:38:35 | Medeon received the Milestone Abandonment Notice from Terumo | |
| SEQ_NO |
1 |
Date of announcement |
2025/05/14 |
Time of announcement |
23:38:35 |
| Subject |
Medeon received the Milestone Abandonment Notice from Terumo |
| Date of events |
2025/05/14
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2025/05/14
2.Company name:Medeon Biodesign, Inc.
3.Relationship to the Company (please enter ‘head office’ or
‘subsidiaries’):head office
4.Reciprocal shareholding ratios:NA
5.Cause of occurrence:
On May 14, 2025, Taipei time, Medeon was notified by Terumo Medical
Corporation (hereinafter referred to as Terumo) that in light of the
pandemic and supply chain challenges, the timeline for launching
Cross-Seal (Large-bore Closure Device) was revised, and has the
potential impact on its original objectives. In accordance of the
Cross-Seal Asset Purchase Agreement and Master Services Agreement,
Terumo proceeded to formally submit the Milestone Abandonment Notice
to Medeon.
Cross-Seal Asset Purchase Agreement is still effective. Both parties
are currently in close communication regarding the subsequent actions
and are actively seeking the most appropriate resolution. It is hoped
that, through continued dialogue, a mutually acceptable and constructive
solution can be reached.
6.Countermeasures:
To publish this announcement.
7.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 9
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):
The development timeline for Cross-Seal is long and entails significant
risks, with no assurance of successful market approval. The expected
milestone-related payments can only be realized upon achievement of the
agreed-upon milestones within the specified timeframe. These factors may
expose the investment to potential risks, and investors are advised to
exercise careful judgment and invest with caution. |
|
| 2025/05/08 | 17:13:03 | Medeon Board of Directors resolved not to proceed the private placement of common shares approved by the 2024 Annual Shareholders’ Meeting. | |
| SEQ_NO |
3 |
Date of announcement |
2025/05/08 |
Time of announcement |
17:13:03 |
| Subject |
Medeon Board of Directors resolved not to proceed the private placement of common shares approved by the 2024 Annual Shareholders' Meeting. |
| Date of events |
2025/05/08
|
To which item it meets |
paragraph 16 |
| Statement |
1.Date of the board of directors resolution for the change:2025/05/08
2.Effective registration date of the original plan:NA
3.Resolution date of additional issuance:NA
4.Major change Reason for the change:
The Company resolved on June 12, 2024 to proceed with the issuing no
more than 35,000,000 common shares for capital increase through private
placement by the Shareholders’Meeting. The issuing shall be completed
within 1 year from the date of the resolution of the Shareholders’
Meeting, with the maximum number of installments not exceeding three.
Due to the period of the private placement proposal is going to expire
and the qualified strategic investors have not yet been identified,
the Medeon board meeting dated May 8, 2025 has resolved not to proceed
the private placement of common shares for rest of the period.
5.Content of each and every successive previously changed
plan for raising of funds before and after change:NA
6.Projected timetable for execution:NA
7.Projected completion date:NA
8.Projected possible benefits:NA
9.Difference from original projected benefits:NA
10.Effect of the current change on shareholder equity:NA
11.Abstract of the original lead underwriter’s appraisal opinion:NA
12.Any other matters that need to be specified:None |
|
| 2025/05/08 | 17:05:52 | Medeon Board of Directors approved the 2025Q1 consolidated financial reports | |
| SEQ_NO |
2 |
Date of announcement |
2025/05/08 |
Time of announcement |
17:05:52 |
| Subject |
Medeon Board of Directors approved the 2025Q1 consolidated financial reports |
| Date of events |
2025/05/08
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of the board of directors submitted or approved:2025/05/08
2.Date of the audit committee approved:2025/05/08
3.Start and end dates of financial reports or unaudited financial
information of the reporting period(XXXX/XX/XX~XXXX/XX/XX):
2025/01/01~2025/03/31
4.Operating revenue accumulated from 1/1 to end of the period
(thousand NTD):101,878
5.Gross profit (loss) from operations accumulated from 1/1 to end of
the period (thousand NTD):19,005
6.Net operating income (loss) accumulated from 1/1 to end of the period
(thousand NTD):(109,442)
7.Profit (loss) before tax accumulated from 1/1 to end of the period
(thousand NTD):(190,856)
8.Profit (loss) accumulated from 1/1 to end of the period
(thousand NTD):(190,538)
9.Profit (loss) during the period attributable to owners of parent
accumulated from 1/1 to end of the period (thousand NTD):(177,993)
10.Basic earnings (loss) per share accumulated from 1/1 to end of
the period (NTD):(1.93)
11.Total assets end of the period (thousand NTD):1,651,716
12.Total liabilities end of the period
(thousand NTD):300,283
13.Equity attributable to owners of parent end of the
period (thousand NTD): 1,343,516
14.Any other matters that need to be specified:None |
|
| 2025/05/08 | 02:37:18 | Medeon announced the preliminary clinical results for the Expander-2 IDE Study in evaluating its BPH minimally invasive treatment device Urocross. | |
| SEQ_NO |
1 |
Date of announcement |
2025/05/08 |
Time of announcement |
02:37:18 |
| Subject |
Medeon announced the preliminary clinical results for the Expander-2 IDE Study in evaluating its BPH minimally invasive treatment device Urocross. |
| Date of events |
2025/05/07
|
To which item it meets |
paragraph 10 |
| Statement |
1.Date of occurrence of the event:2025/05/07
2.New drug name or code:
Urocross Expander System and Urocross Retrieval Sheath
3.Indication:
Urocross is a retrievable and non-permanent implant based treatment,
which is placed within the prostatic urethra using a standard flexible
cystoscope commonly used for urological cystoscopy. The procedure is
performed under mild sedation while the implant to be gently placed
into the prostate-urethra. This provides immediate relief of BPH
(Benign Prostatic Hyperplasia) symptoms while modifying the obstruction.
After six months, Urocross can be removed using the standard flexible
cystoscope, ensuring that no permanent implant is left behind.
4.Planned development stages:
While the data collection and evaluation of the primary endpoint is
completed, the clinical study details will be reviewed by the U.S.
FDA prior to the official submission of the market approval application.
5.Current development stage:
The preliminary analysis of clinical results for the Expander-2 IDE
Study in evaluating the BPH minimally invasive treatment device
Urocross has been completed.
Pivotal, multi-national and multi-center, randomized, sham-controlled,
blinded study
Evaluate the safety and efficacy for the Urocross Expander System and
Retrieval Sheath treating lower urinary tract symptoms (LUTS)
associated with BPH
Pivotal IDE Study
Urocross Expander System and Urocross Retrieval Sheath
Treating lower urinary tract symptoms (LUTS) associated with BPH
Primary Outcome Measures:
i.Safety: The rate of extended post-operative urinary catheterization
(more than 7 days) from treatment for inability to void.
ii.Efficacy: The average improvement in IPSS among the experimental
group is more than 25% greater than the average improvement in IPSS
among the sham control group at 3 months post-procedure.
Secondary Outcome Measures
Percent change in IPSS from baseline (i.e., pre-procedure) to 3 months
post-procedure for subjects randomized to the Urocross Implant group
is greater than 30%.
A total of 240 patients were randomized 2:1 to the Urocross experimental
group and the sham control group (intervene by cystoscopy without
further treatment).
Safety Endpoint: According to the statistical results of the study,
no serious adverse events related to the procedure or device. The
percentage of subjects who were left with catheter for more than 7 days
due to difficulty in urination was 0.6%.
Efficacy Endpoint: The trial results showed that the treatment group
achieved average improvements in the International Prostate Symptom
Score (IPSS) of 25.7%, 32.6%, 44.5%, and 52.1% at 3 months (N=158),
6 months (N=129), 7 months (N=107), and 12 months (N=68) post-treatment,
respectively, with all p-values less than 0.0001. The IPSS improvement
in the Urocross treatment group reached the 30% benchmark outlined in
the FDA’s guidance for BPH treatments at 6 months post-procedure.
Additionally, the treatment group showed a 25% greater improvement
than the sham control group at the six-month period.
Once the full clinical study report is finalized, the trial data will
undergo inspection by the U.S. FDA to ensure its accuracy and
reliability. Concurrently, additional clinical data will continue to be
collected, with plans to formally submit a marketing application to
the FDA by the end of 2025. During its review, the FDA will evaluate
the application based on the requirements outlined in its guidance for
BPH treatments, as well as the safety and efficacy profiles of
comparable products already on the market, to determine whether
Urocross offers meaningful clinical benefit to patients.
While the data collection and evaluation of the primary endpoint is
completed, the clinical study details will be reviewed by the U.S.
FDA prior to the official submission of the market approval
application.
Due to the involvement of information pertaining to future international
licensing negotiations, and to avoid impacting the licensing amount
while safeguarding the rights and interests of investors, the details
will not be disclosed at this time.
6.Upcoming development plan:
Officially submit the market approval application to the US FDA.
7.Market situation:
The probability of men suffering from BPH increases with age. The
estimated population in only the United States with BPH is reaching
40 million. As the population continues to age, the number of BPH
patients is expected to grow accordingly. According to a market research
report by Grand View Research published in 2023, the global market for
medical devices treating BPH reached USD 1.42 billion in 2022. It is
projected that from 2023 to 2030, the BPH-related market will grow at a
compound annual growth rate (CAGR) of 8.9%.
8.Any other matters that need to be specified(the information
disclosure also meets the requirements of Article 7, subparagraph 8
of the Securities and Exchange Act Enforcement Rules, which brings
forth a significant impact on shareholders rights or the price of
the securities on public companies.):
While the data collection and evaluation of the primary endpoint is
completed, the clinical study details will be reviewed by the U.S.
FDA prior to the official submission of the market approval
application. Relevant information will be disclosed from time to
time in accordance with applicable laws and regulations.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.: |
|
