| 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.: |
|
| 2025/05/07 | 18:31:37 | Medeon is invited to attend the investor conference held by MasterLink Securities | |
| SEQ_NO |
2 |
Date of announcement |
2025/05/07 |
Time of announcement |
18:31:37 |
| Subject |
Medeon is invited to attend the investor conference held by MasterLink Securities |
| Date of events |
2025/05/07
|
To which item it meets |
paragraph 12 |
| Statement |
1.Date of institutional investor conference:2025/05/08
2.Time of institutional investor conference:15:30
3.Location of institutional investor conference:
11F., No. 97, Sec. 2, Dunhua S. Rd., Taipei City (Tunnan Tower, 11F.,
Education and Training Room in MasterLink Securities)
4.Outline of institutional investor conference:
The Company is invited to attend the investor conference held by
MasterLink Securities to explain the preliminary clinical results
from the pivotal study of Urocross.
5.Any other matters that need to be specified:None |
|
| 2025/05/07 | 18:20:57 | Announcement of the material information released at the press conference | |
| SEQ_NO |
1 |
Date of announcement |
2025/05/07 |
Time of announcement |
18:20:57 |
| Subject |
Announcement of the material information released at the press conference |
| Date of events |
2025/05/07
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2025/05/07
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:
Medeon Biodesign Announces Positive Preliminary Results from Urocross’
Pivotal Trial
6.Countermeasures:
Medeon held a material information press conference at the Taipei
Exchange (TPEx) at 17:00, 7 May, 2025. The content of the press
release from the conference is as follows:
Medeon Biodesign announced that its pivotal IDE study for Urocross,
conducted across the United States and Canada, delivered positive
results. The treatment group demonstrated mean improvements in
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?Xall with p-values
below 0.0001. These findings indicate that therapeutic effects were
not only sustained but continued to improve significantly after implant
retrieval, reaching the 30% improvement benchmark outlined in the FDA’s
guidance for BPH treatment by the six-month mark. The study group also
outperformed the sham control group by 25%, with this difference becoming
evident at six months. Additional efficacy endpoints showed similarly
strong results, including significant improvements in quality of life
(QOL) and peak urinary flow rate (Qmax), while sexual function, as
measured by the MSHQ-EjD score, remained well preserved.
Notably, Urocross demonstrated an exceptional safety profile, with no
procedure or device related serious adverse events (SAEs) reported, and
the rates of other adverse events were either comparable to or
significantly lower than those seen with similar products. Pain?Xoften
a top concern for patients?Xwas minimal, with VAS scores of just 2.5
for the implantation procedure and 2.0 for retrieval, markedly better
than the typical score of 4-6 reported for comparable treatments.
Additionally, only 0.6% of patients require catheterization for more
than seven days, a safety indicator that also outperforms competing
therapies. These results further highlight Urocross’ minimally
invasive nature and superior patient comfort, reinforcing its
differentiated market positioning.
Subgroup analysis showed that Urocross demonstrated particularly strong
efficacy in patients with moderate to severe symptoms (baseline IPSS of
20?V35), with IPSS improvements of 35.8%, 48.9%, and 52.7% observed at
6 months (N=108), 7 months (N=90), and 12 months (N=57), respectively.
The treatment was especially effective in patients who had not used
medication prior to enrollment, had no bladder-related symptoms
(Void/Storage >1), and had prostate volumes between 30?V50 grams.
Additionally, 85% of patients in the sham control group opted to cross
over to receive treatment after three months. This crossover group
achieved a 39.8% improvement in IPSS at the three-month mark (N=50),
representing a patient population that closely reflects real-world
clinical scenarios.
Dr. Dan Rukstalis, a world-renowned Urologist at Virginia Tech
Carilion Clinic and Co-Principal Investigator of the Expander-2 Trial,
added ‘The removable design of the Urocross Expander as a
non-permanent prostatic implant creates a new paradigm for the
treatment of men with BPH who want to avoid tissue resection and
sexual dysfunction. The fact that this system works without cutting,
burning, ablating, or leaving a permanent foreign body inside the
prostate is truly revolutionary and it serves as the least invasive
treatment option as compared to other tissue-respecting technologies.
Urocross opens up a whole new world of possibilities for how we
approach treatment, offering patients effective sustained symptom
relief with minimal intervention.’
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.
BPH affects a large population, with over 40 million men impacted in
the United States alone. Due to concerns over postoperative discomfort,
long recovery times, and the risk of sexual dysfunction, only about
1% of patients opt for traditional surgical resection each year.
As a result, many patients continue to endure a decline in quality
of life while delaying treatment. In recent years, emerging minimally
invasive therapies have provided more options for patients. However,
some procedures still require postoperative catheterization, and those
involving permanent metallic implants may interfere with MRI imaging
or require invasive removal. These clinical pain points highlight
the unmet need for safer, more comfortable, and flexible treatment
options, creating a significant market opportunity for Urocross.
Chairman and CEO of Medeon, Dr. Yue-Teh Jang stated that the
development of Urocross was driven by the goal of striking a balance
between treatment comfort and clinical efficacy, aiming to offer a
new option with greater comfort than existing minimally invasive
therapies. Building on the positive results from earlier Expander-1
feasibility studies, this trial further validated Urocross’
performance through large-scale data. The improvement in IPSS was
comparable to that of similar products, while Urocross stood out for
its significantly superior safety profile, demonstrating an exceptional
overall performance and fulfilling its original development vision.
The team remains fully committed to accelerating the path to
regulatory approval, with market clearance as the top priority.
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.):None |
|
| 2025/04/30 | 15:35:23 | Announcement of Change in the Company’s Acting Spokesperson | |
| SEQ_NO |
2 |
Date of announcement |
2025/04/30 |
Time of announcement |
15:35:23 |
| Subject |
Announcement of Change in the Company's Acting Spokesperson |
| Date of events |
2025/04/30
|
To which item it meets |
paragraph 8 |
| Statement |
1.Type of personnel changed (please enter:
spokesperson, acting spokesperson, important
personnel (CEO, COO, CMO, CSO, etc.), financial
officer, accounting officer, corporate governance
officer, chief information security officer,research
and development officer, internal audit officer, or
designated and non-designated representatives): Acting Spokesperson
2.Date of occurrence of the change: 2025/04/30
3.Name, title, and resume of the previous position holder:
Elisa Huang / Acting Spokesperson
4.Name, title, and resume of the new position holder:
Pearl Ling / Assistant Manager of Finance & Business Analysis
5.Type of change (please enter: ‘resignation’,
‘position adjustment’, ‘dismissal’, ‘retirement’,
‘death’ or ‘new replacement’): Position adjustment
6.Reason for the change: Position adjustment
7.Effective date: 2025/05/01
8.Any other matters that need to be specified: N/A |
|
| 2025/04/30 | 15:30:29 | Announcement of the Board of Directors Meeting Date for Approval of the First-Quarter 2025 Financial Report | |
| SEQ_NO |
1 |
Date of announcement |
2025/04/30 |
Time of announcement |
15:30:29 |
| Subject |
Announcement of the Board of Directors Meeting Date for Approval of the First-Quarter 2025 Financial Report |
| Date of events |
2025/04/30
|
To which item it meets |
paragraph 31 |
| Statement |
1.Date of a notice of the board of directors meeting is issued:2025/04/30
2.Expected date of the board of directors meeting is convened:2025/05/08
3.Expected year and quarter of the financial reports
or the annual self-assessed financial information
submitted to the board of directors or approved by
the board of directors: First-Quarter 2025
4.Any other matters that need to be specified:None |
|
| 2025/04/23 | 16:55:49 | Announcement of Medeon’s fund loans and over-limit improvement plan | |
| SEQ_NO |
2 |
Date of announcement |
2025/04/23 |
Time of announcement |
16:55:49 |
| Subject |
Announcement of Medeon’s fund loans and over-limit improvement plan |
| Date of events |
2025/04/23
|
To which item it meets |
paragraph 53 |
| Statement |
1.Date of occurrence of the event:2025/04/23
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:
Due to the decrease in net worth reported in the audited financial
statements for the fourth quarter of 2024, the amount of the Company’s
loan to its subsidiary, PMC, has exceeded the limit for loans to
a single entity.
6.Countermeasures:
PMC is currently conducting a cash capital increase by issuing 4,125,000
shares of Series E preferred stock, with a target fundraising amount of
NT$330,000,000. Upon completion of the capital increase, the company plans
to repay the principal and interest to Medeon at an annual interest rate
of 3%. Medeon thereby resolves the issue of exceeding the loan limit for
a single entity.
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.):None |
|
