Summary

• Page properties (1 modified, 0 added, 0 removed)

Details

Page properties

Content

...	...	@@ -4,7 +4,7 @@
4	4
5	5	= Overview =
6	6
7		-Proteon Therapeutics (PRTO) is a late-stage biopharmaceutical company focused on the development of novel, first-in-class pharmaceuticals to address the needs of patients with renal and vascular disease. The company's product candidate, vonapanitase, is a recombinant human elastase that Proteon Therapeutics is developing to improve vascular access outcomes in patients with chronic kidney disease, or CKD, undergoing or planning for hemodialysis, a lifesaving treatment that cannot be conducted without a functioning vascular access. The company believe data from its completed Phase 2 and Phase 3 clinical trials of vonapanitase support that a one-time, local application of investigational vonapanitase during surgical creation of a radiocephalic fistula for hemodialysis may improve fistula use for hemodialysis and secondary patency (time to fistula abandonment), thereby improving patient outcomes and reducing the burden on patients and the healthcare system.{{footnote}}https://fintel.io/doc/sec-prto-proteon-therapeutics-10k-2018-march-14-17944{{/footnote}}
	7	+Proteon Therapeutics is a late-stage biopharmaceutical company focused on the development of novel, first-in-class pharmaceuticals to address the needs of patients with renal and vascular disease. The company's product candidate, vonapanitase, is a recombinant human elastase that Proteon Therapeutics is developing to improve vascular access outcomes in patients with chronic kidney disease, or CKD, undergoing or planning for hemodialysis, a lifesaving treatment that cannot be conducted without a functioning vascular access. The company believe data from its completed Phase 2 and Phase 3 clinical trials of vonapanitase support that a one-time, local application of investigational vonapanitase during surgical creation of a radiocephalic fistula for hemodialysis may improve fistula use for hemodialysis and secondary patency (time to fistula abandonment), thereby improving patient outcomes and reducing the burden on patients and the healthcare system.{{footnote}}https://fintel.io/doc/sec-prto-proteon-therapeutics-10k-2018-march-14-17944{{/footnote}}
8	8
9	9	Arteriovenous fistulas are the gold standard of vascular access for hemodialysis, given they are associated with fewer complications and reduced rates of hospitalization as compared to other forms of vascular access. The company estimate there are approximately 130,000 fistulas created in the United States annually, a procedure in which a surgeon transects a vein and sutures it to the side of a nearby artery, typically in the arm. Radiocephalic fistulas created in the forearm are the preferred form of arteriovenous fistula because they preserve the maximum number of future sites for vascular accesses (i.e., the potential use of other vascular access sites further up in the arm) and are associated with the lowest rate of serious complications such as steal syndrome (hand ischemia).
10	10
...	...	@@ -36,8 +36,6 @@
36	36
37	37	The company believe that, if its ongoing Phase 3 clinical trial is successful and vonapanitase is approved, vonapanitase will potentially become the standard of care for patients with CKD undergoing surgical creation of a radiocephalic fistula. The company retain worldwide commercial rights to vonapanitase. If approved by regulatory authorities, the company intend to commercialize this product in the United States itself  with a specialty sales force, focused primarily on vascular surgeons. The company also intend to seek one or more collaborators to commercialize the product in additional markets, including Europe and China. The company's patents include claims covering formulations, methods of manufacturing and use of elastases, providing protection in the United States into 2030 and European Union through 2028, with potential extension into 2033 in the United States and in the European Union.
38	38
39		-{{putFootnotes/}}
40		-
41	41	= Strengths =
42	42
43	43	The company believe its company and vonapanitase possess the following attributes that increase the likelihood that the company will be successful in developing and commercializing vonapanitase: