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Page 1: 2e6664 - RevaFlex 4-Page Brochure...2e6664 - RevaFlex 4-Page Brochure.indd Created Date 10/3/2013 4:49:18 PM

1-888-705-ISTO (4786) | www.istotech.comRevaFlex is a trademark of ISTO Technologies, Inc.

US Patents Nos. 6,235,316; 6,645,764; and 7,087,227.

RevaFlex™ shows potential for repair of articular cartilage defects of the knee.4

HOPE RESTORED.

References

1. Adkisson HD, Gillis MP, Davis EC, Maloney WJ, Hruska KA. In vitro generation of scaffold independent neocartilage. Clin Orthop Relat Res. 2001;391S:S280-S294.

2. Adkisson HD, Milliman C, Zhang X, Mauch K, Maziarz RT, and Streeter PR. Immune evasion by neocartilage-derived chondrocytes: Implications for biologic repair of joint articular cartilage. Stem Cell Research. 2010: 4: 57-68.

3. Adkisson HD, Martin JA, Amendola RL, et al. The potential of human allogeneic juvenile chondrocytes for restoration of articular cartilage. Am J Sports Med. 2010;38:1324-1333.

4. Cole BJ, Farr J, Bonner K, Gold G, and Adkisson HD. Clinical and functional outcomes of RevaFlex, a tissue-engineered cartilage implant derived from allogeneic juvenile chondrocytes. Poster presented at the 11th World Congress of the International Cartilage Repair Society; 2013 Sept. 15–18; Izmir, Turkey.

13-1032

A. Focal cartilage defect in 27-yr old female, prepared for RevaFlex treatment.

B. Arthroscopic image of same articular cartilage defect, 12 months post-surgery.

A B

Average percent fi ll of articular cartilage lesion as determined by MRI, post RevaFlex implantation.

RevaFlex Phase I/II clinical study results demonstrate promise for regenerating articular cartilage.

60%

4Weeks

MRI Findings – Percent Fill of Lesion

6Months

12Months

24Months

36Months

48Months

65%

70%

75%

80%

85%

The results of the subject-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) showed continued improvement out to 48 months after treatment.

Knee Injury and Osteoarthritis Outcome ScoreMRI Findings — Percent Fill of Lesion

Data from the completed Phase I/II clinical trial shows promising effi cacy at the 4-year mark.

CURRENTLY IN CLINICAL STUDIES

Page 2: 2e6664 - RevaFlex 4-Page Brochure...2e6664 - RevaFlex 4-Page Brochure.indd Created Date 10/3/2013 4:49:18 PM

POWER POSSIBILITY.

The RevaFlex graft is about 0.5–1.0mm thick and highly fl exible, which allows it to easily conform to the defect and potentially be delivered through arthroscopic instrumentation.

RevaFlex is a living, cell-based therapy that takes advantage of the superior bioactivity of juvenile cartilage cells. Juvenile cartilage cells have been proven to have far greater regenerative potential than adult cells1 and are known to be immune-privileged.2

NOT JUST THE SAME, BETTER.

Level of Chondrocyte Matrix Production1,3

RevaFlex is a scaffold-free living cartilage implant, currently in clinical studies designed for the repair and regeneration of knee cartilage.

• Patented juvenile cell-based technology, with more potent regenerative properties than adult chondrocytes

• Potential to produce hyaline cartilage similar to cartilage in young, healthy joints

• Single-step application procedure, with the potential to reduce costs and donor site morbidity

• Scalable technology offers the ability to meet large-scale demand

HUMANS WERE NOT BUILT TO BE STATIC. From the beginning, humans have been engineered to move: to run and jump and soar. And while we continue to be driven by this instinct, nature and time and coincidence may have other plans.

RevaFlex™ is evolution. Adaptation.

It’s promise disguised as a cartilage implant.

It’s humanity cloaked in science.

Page 3: 2e6664 - RevaFlex 4-Page Brochure...2e6664 - RevaFlex 4-Page Brochure.indd Created Date 10/3/2013 4:49:18 PM

1-888-705-ISTO (4786) | www.istotech.comRevaFlex is a trademark of ISTO Technologies, Inc.

US Patents Nos. 6,235,316; 6,645,764; and 7,087,227.

RevaFlex™ shows potential for repair of articular cartilage defects of the knee.4

HOPE RESTORED.

References

1. Adkisson HD, Gillis MP, Davis EC, Maloney WJ, Hruska KA. In vitro generation of scaffold independent neocartilage. Clin Orthop Relat Res. 2001;391S:S280-S294.

2. Adkisson HD, Milliman C, Zhang X, Mauch K, Maziarz RT, and Streeter PR. Immune evasion by neocartilage-derived chondrocytes: Implications for biologic repair of joint articular cartilage. Stem Cell Research. 2010: 4: 57-68.

3. Adkisson HD, Martin JA, Amendola RL, et al. The potential of human allogeneic juvenile chondrocytes for restoration of articular cartilage. Am J Sports Med. 2010;38:1324-1333.

4. Cole BJ, Farr J, Bonner K, Gold G, and Adkisson HD. Clinical and functional outcomes of RevaFlex, a tissue-engineered cartilage implant derived from allogeneic juvenile chondrocytes. Poster presented at the 11th World Congress of the International Cartilage Repair Society; 2013 Sept. 15–18; Izmir, Turkey.

13-1032

A. Focal cartilage defect in 27-yr old female, prepared for RevaFlex treatment.

B. Arthroscopic image of same articular cartilage defect, 12 months post-surgery.

A B

Average percent fi ll of articular cartilage lesion as determined by MRI, post RevaFlex implantation.

RevaFlex Phase I/II clinical study results demonstrate promise for regenerating articular cartilage.

60%

4Weeks

MRI Findings – Percent Fill of Lesion

6Months

12Months

24Months

36Months

48Months

65%

70%

75%

80%

85%

The results of the subject-reported Knee Injury and Osteoarthritis Outcome Score (KOOS) showed continued improvement out to 48 months after treatment.

Knee Injury and Osteoarthritis Outcome ScoreMRI Findings — Percent Fill of Lesion

Data from the completed Phase I/II clinical trial shows promising effi cacy at the 4-year mark.

CURRENTLY IN CLINICAL STUDIES